Search Weight Loss Topics:




Feb 29

Top 13 Strongest Testosterone Boosters Ranked: Best Brands to Buy in 2024 | HeraldNet.com – The Daily Herald

Some men naturally have a lower testosterone level than others. Others have low testosterone due to age, genetics, lifestyle, or dieting. While low testosterone levels can be devastating to any mans body and mind in itself, there are ways of boosting testosterone production naturally that dont involve any medication or other artificial substances (or expensive TRT, testosterone replacement therapy).

Yes, thats true! Boosting testosterone levels without resorting to anabolic steroids is possible. Today, some of the worlds best natural testosterone boosters claim to raise testosterone levels without the side effects of anabolic steroids. By taking these testosterone supplements daily, you can purportedly support healthy male testosterone, giving you high energy levels, weight loss results, and muscle gain.

So, if you are looking for the best testosterone boosters for 2024? Which testosterone-boosting supplements live up to the hype? Find out everything you need to know today in our guide to testosterone booster supplements.

Our editorial team interviewed manufacturers, analyzed labels, and read countless clinical trials to determine the best testosterone supplements of 2024. Below are our rankings of the best testosterone boosters of this year.

Lets jump right into the heart of the matter and review the top best testosterone boosters for men looking to naturally boost testosterone levels:

Product Classification

Whats in it: These premium testosterone pills are formulated with the help of Ashwagandha, Fenugreek, Zinc, L-Arginine HCL, Panax Ginseng, D-aspartic acid, Vitamin D3, Garlin, and Magnesium.

Supplement Features:

Serving Instructions: Take four capsules with a glass of water daily

Check Official Website: Testosil.com

Testosil stands unchallenged as the best natural testosterone booster available in the market today to promote testosterone production. Leveraging a potent testosterone booster formulated with patented ingredients, it promises an impressive increase of up to 434% in testosterone levels, more than what exercise alone can deliver.

Sourced from FDA-registered and inspected facilities and created following cGMP-certified manufacturing processes, Testosil offers a safer alternative to synthetic testosterone boosters, aiding in harmonizing hormone balance and enhancing sexual function.

Complementing a healthy diet it empowers men to boost testosterone naturally, fostering greater muscle size and strength, as evidenced in a groundbreaking study. Choose Testosil, the epitome of potency and reliability, and redefine the boundaries of your physical and sexual well-being.

Product Classification

Whats in it: Trigonella foenum-graecum and Furosap

Supplement Features:

Serving Instructions: Consume one pill every day

Check Official Website: Primegenix.com

Last on our list, PrimeGENIX Testodren has recently launched a formula for boosting free testosterone levels in the body. With Testodren, you can choose a healthy and natural alternative to testosterone products that only partially work and leave destruction behind. The product is completely safe because it has no side effects. It is a great option available in the testosterone supplement market.

Product Classification

Whats in it: With Testogen testosterone pills, you get a combination of fenugreek, D-aspartic acid, Nettle Leaf Extract, Zinc, Vitamin D3, and other herbal extracts, minerals, and nutrients linked to a higher testosterone level.

Supplement Features:

Serving Instructions: It is best to take 4 Testogen pills daily, 20 minutes before breakfast.

Check Official Website: Tesogen.com

Testogen is the best testosterone booster supplement that claims to target energy levels, muscle growth, sex drive, and overall male performance. Some people take Testogen to lose weight. Others take it to accelerate lean muscle mass. Some just want to raise their sex drive. Several ingredients in these best testosterone pills further ensure the healthy production of sex hormone-binding globulin to balance androgens and estrogens.

Testogen contains zero steroids; therefore, it will naturally increase testosterone levels in men. Testogen is manufactured by a well-known American company. According to the makers of this natural testosterone booster, you will notice health improvements within a fortnight of beginning use.

Product Classification

Whats in it: Prime Male contains strong doses of Vitamin D3, Vitamin K2, Vitamin B6, Magnesium, BioPerine, Zinc, D-Aspartic Acid Calcium Chelate, Asian Red Ginseng, Luteolin, Mucuna Pruriens, Nettle Root Extract, and Boron (as boron amino acid chelate)

Supplement Features:

Serving Instructions: After a meal, take 4 capsules of Prime Male every day

Check Official Website: Primemale.com

Prime Male testosterone boosting supplement is one of the fanciest formulas on this list, delivering a higher dose of proven testosterone-boosting ingredients than most of its competitors. The makers of Prime Male claim their formula could raise testosterone as high as 42% in under two weeks. It also has a genuine celebrity endorsement from Dolph Lundgren, of all people.

The formula contains a potent ingredient called Luteolin, which balances the luteinizing hormone and follicle-stimulating hormone to increase testosterone production naturally.

Priced at $69 per bottle, its not as cheap as other testosterone-boosting supplements on this list, but Prime Male emphasizes good value by using stronger doses of active natural ingredients. Advertised benefits include higher energy and libido, improved lean muscle mass, controlled blood sugar levels, and better overall performance, among other health benefits.

Product Classification

Whats in it: The manufacturer claims that each serving of TestoPrime contains 8,000mg of Panax ginseng, 2,000mg of D-aspartic acid, 800mg of fenugreek extract, and 668 mg of ashwagandha extract, all of which are the strongest doses on this list.

Supplement Features:

Serving Instructions: Consume four capsules of Testoprime before breakfast each day

Check Official Website: Tesoprime.com

Testo Prime testosterone boosting supplement contains some of the strongest doses on this list. To put that dosage in perspective, we dont see a dosage this strong, even with scoops of protein powder.

Testo Prime has packed an unusually strong dose of only natural ingredients into each capsule of its formula. By taking one four-capsule serving of Testo Prime daily, you can purportedly lose weight, increase lean muscle mass, and raise testosterone, among other noticeable health benefits. It has got amazing customer reviews to impress us.

Product Classification

Whats in it: The blend includes Fenugreek Extract, D-Aspartic Acid, Vitamins D, K2, and B6, Magnesium, Oyster Extract, Ginseng, and Zinc to increase testosterone levels naturally.

Supplement Features:

Serving Instructions: Take 4 capsules per day in an instructed time gap to boost testosterone levels

Check Official Website: Testofuel.com

The makers of TestoFuel advertise their formula as an anabolic support complex, suggesting it supports testosterone by targeting your natural anabolism. Using only natural ingredients, TestoFuel claims to offer optimal testosterone levels with D-aspartic acid, vitamin D, and even oyster extract, among other proven compounds.

Each serving of TestoFuel testosterone-boosting supplement works to help with sex drive, virility, testosterone, muscle growth, body fat burning, and more. You take four capsules per serving to support testosterone.

Product Classification

Whats in it: Testolab Pro fuels up your testosterone with D-Aspartic Acid, Oyster Extract, Ginseng, Fenugreek, Magnesium, Vitamin B, Vitamin K2, Zinc

Supplement Features:

Serving Instructions: Consume 2 capsules in the morning and 2 in the evening to support healthy testosterone levels

Check Official Website: Testolabpro.com

TestoLab Pro delivers 120 capsules of testosterone-boosting power in each bottle. Each bottle includes natural ingredients to protect, sustain, and potentiate testosterone circulating through your body. Like other testosterone supplements, TestoLab Pro claims to specifically improve free testosterone levels and boost luteinizing hormone production.

Testosterone is only useful when circulating through your bloodstream. With TestoLab Pro, you get effective natural ingredients to support weight loss, muscle-building, stress response, sex drive, and even bone strength, among other unique effects.

Product Classification

Whats in it: HunterTest testosterone pills contain the following natural ingredients: Asian Ginseng, Ashwagandha, Boron Chelate, D-aspartic acid, Vitamin K2, Vitamin D, Zinc, Indole-3-Carbinol, and Magnesium.

Supplement Features:

Serving Instructions: Take 6 capsules every day with a glass of water

Check Official Website: Hunterevolve.com

Hunter Tests stylish packaging masks a supplement with strong doses of multiple active ingredients linked to healthy testosterone levels. The customer reviews section says everything. We like the natural testosterone booster Hunter Test because it combines vitamins and minerals crucial for testosterone production with herbal extracts linked to libido and sex drive.

Together, these best testosterone booster pills could help you support testosterone production from multiple angles. Thats why the makers of Hunter Test describe their formula as a total testosterone-boosting package. If you like stylish packaging, then its also tough to beat Hunter Test.

Product Classification

Whats in it: Boswellia extract (Frankincense), Ashwagandha, Shilajit, Tongkat Ali, Korean Red Ginseng, Magnesium, Zinc, Vitamin D, and Vitamin B6

Supplement Features:

Serving Instructions: Experts recommend taking 2 capsules daily

Check Official Website: SilentMalePlague.com

Zenith Labs makes an effective testosterone booster called Barbarian XL. The supplement is also one of the few on this list that was genuinely formulated and approved by a doctor. Dr. Ryan Shelton is the Chief Medical Officer for Zenith Labs, and he used his experience in naturopathy to create the Barbarian XL formula.

Barbarian XL features unique ingredients we dont see with other testosterone boosters on this list, and it could work differently by targeting different pathways. Barbarian XL contains Boswellia resin extract, ashwagandha, shilajit, ginseng, and other ingredients traditionally used in various fields of Asian medicine.

Product Classification

Whats in it: Tongkat Ali, L-Norvaline, Avena Sativa, Cordyceps Sinensis, Rhodiola Rosea, and Tribulus Terrestris are all included in T20 to help boost testosterone levels.

Supplement Features:

Serving Instructions: Swallow 2 capsules every day for at least 3 months

Check Official Website: Saveyourmojo.com

Dont let JayLab Pro T20s bland packaging fool you: the supplement claims to boost your testosterone and turn back your body clock by 20 years with just 30 seconds of supplementation per day. By taking two capsules of T20 daily, you can give your body the ingredients it needs to support testosterone production. T20 uses ingredients we expect to see in a testosterone booster, including Tongkat Ali and Tribulus Terrestris.

The natural testosterone booster also contains unique ingredients and mechanisms we dont always expect to see, including L-norvaline and Avena sativa for targeting blood flow. These ingredients could enhance vitality from multiple angles. Instead of just boosting testosterone, T20 could support blood flow and other benefits. At under $40, its also one of the most affordable natural testosterone boosters on our list.

Product Classification

Whats in it: Each serving of Testo-Max includes D-aspartic acid, vitamin D3, magnesium, Bioperine(05% Piperine), Korean red ginseng, nettle leaf extract, fenugreek, and other herbal extracts, vitamins, minerals, and nutrients associated with testosterone production in the male body.

Supplement Features:

Serving Instructions: Take 4 capsules before 20 minutes of breakfast

Check Official Website: Crazybulk.com

The last strongest testosterone booster, CrazyBulk, is best known for its bodybuilding supplements, including formulas that help with cutting, bulking, and boosting strength. With Testo-Max, the supplement improves bodybuilding results from a different angle: by supporting testosterone production. It has Nettle leaf extract that improves blood flow and healthy testosterone levels by preventing the free testosterone from binding to sex hormone-binding globulin.

CrazyBulks Testo-Max is advertised as a strength and energy supplement and a natural alternative to higher-powered products. Its part of CrazyBulks Mass Series.

Product Classification

Whats in it: Fenugreek Seed Extract, D-aspartic Acid, ZMA, Vitamin K2, Vitamin B6 (Pyridoxine HCl), Zinc, Magnesium, and Vitamin D3

Supplement Features:

Serving Instructions: Swallow 4 capsules each day in two doses

Check Official Website: TestRX.com

TestRX is a natural testosterone supplement that uses vitamin D, vitamin B6, and other vitamins and minerals crucial for male sexual health. TestRX emphasizes similar benefits to competing supplements. It has Vitamin D3, which is a fat-soluble vitamin to increase the absorption of calcium and phosphorus.

By taking TestRX daily, you can purportedly put on stacks of lean, hard muscle mass at any age. The supplement is primarily advertised to men who want to increase muscle mass, muscle tone, and burn body fat. However, its also marketed as a sexual health supplement and libido booster that raises free testosterone levels. With multiple effects and angles, TestRX aims to be the best testosterone booster for men of any age.

Product Classification

Whats in it: With Testo 911, you get a formula with modest doses of magnesium, Diindolylmethane (DIM), Eurycoma Longifolia, zinc, Rhodiola Rosea, and other ingredients.

Supplement Features:

Serving Instructions: Take 2 capsules of Testo 911 every day

Check Official Website: Testo911.com

Testo 911 is one of many 911 supplements from PhytAge Labs targeting different health and wellness goals. The company is known for its unusual marketing campaigns and dramatic sales videos. PhytAge Labs claims their formula will naturally boost testosterone levels, increase energy levels, support blood flow, reduce inflammation, and aid in a healthy metabolism, among other benefits. Just take it daily to enjoy all of these benefits and more.

Testosterone booster companies make similar promises: they all claim to support healthy testosterone, increase muscle growth, and give you the energy and sex drive you had as a younger man.

However, few testosterone boosters live up to those promises. To separate the best and worst testosterone booster supplements from one another, we considered all of the following factors in our rankings:

The goal of the best testosterone booster is to replicate the effects of anabolic steroids using legal, natural, safe ingredients. Some testosterone boosters use vitamins and minerals. Others use herbal extracts or amino acids. Some ingredients are backed by real scientific evidence, while others are not.

Want to know a secret? The two most important testosterone-boosting ingredients are vitamin D and zinc, both of which are available in an average multivitamin. You can find multivitamins for less than $10, while the testosterone boosters above cost $40 and up. Thats why we considered the uniqueness of the formula in our rankings. Youre buying the best testosterone booster for more than just zinc and vitamin D.

Here is the original post:
Top 13 Strongest Testosterone Boosters Ranked: Best Brands to Buy in 2024 | HeraldNet.com - The Daily Herald

Read More..

Feb 5

Lipocine Announces Continued Commercialization of TLANDO through Verity Pharmaceuticals – BioSpace

SALT LAKE CITY, Feb. 2, 2024 /PRNewswire/ -- Lipocine Inc.(NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that commercialization of TLANDO in the U.S. has been transitioned to its licensee Verity Pharmaceuticals, effective February 1, 2024, enabling the continuity of patient access to TLANDO. TLANDO is the first and only oral testosterone replacement therapy (TRT) option approved by the US Food and Drug Administration (FDA) that does not require dose titration.

In January 2024, Lipocine and Gordon Silver Limited entered into an exclusive license agreement under which Verity Pharma will market TLANDO inthe United States and, if approved, in Canada. Under the terms of the license agreement, Lipocine has received the second tranche of the $11 million license fee, $5 million. In addition, per the license agreement, Gordon Silver Limited is to make license fee payments of $2.5 million and $1 million no later than January 1, 2025, and January 1, 2026, respectively.

About TLANDO

TLANDO is approved by the FDA as a testosterone replacement therapy ("TRT") in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). TLANDO was developed using Lipocine's proprietary Lip'ral drug delivery technology platform.

For full prescribing information, please visitwww.TLANDO.com.

IMPORTANT SAFETY INFORMATION

TLANDO (testosterone undecanoate) capsules, for oral use, CIII

Initial U.S. Approval: 1953

IMPORTANT SAFETY INFORMATION

WARNING: BLOOD PRESSURE INCREASES (See Boxed Warning on Product Label for more information)

TLANDO can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease.

Before initiating TLANDO, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled.

Three weeks after initiating therapy monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension.

Re-evaluate whether the benefits of TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment. Due to this risk, use TLANDO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.

TLANDO INDICATIONS AND USAGE

TLANDO (testosterone undecanoate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

Primary hypogonadism (congenital or acquired)

Hypogonadotropic hypogonadism (congenital or acquired)

LIMITATIONS OF USE

Safety and efficacy of TLANDO in males less than 18 years old have not been established.

CONTRAINDICATIONS

TLANDO is contraindicated in:

Patients with carcinoma of the breast or known or suspected carcinoma of the prostate.

Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman.

Known hypersensitivity to testosterone undecanoate or any of TLANDO's ingredients.

Men with hypogonadal conditions, such as "age-related hypogonadism", that are not associated with structural or genetic etiologies. The efficacy of TLANDO has not been established for these conditions, and TLANDO can increase BP that can increase the risk of MACE.

WARNINGS AND PRECAUTIONS

Increase in Blood Pressure: In Study 18-001, TLANDO increased systolic BP after 4 months of treatment by an average of 4.3 mmHg based on ambulatory blood pressure monitoring (ABPM) and 4.8 mmHg from baseline based on blood pressure cuff measurements [see Adverse Reactions (6.1)].

These BP increases can increase the risk of major adverse cardiovascular events (MACE), with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease.

In some patients, the increase in BP with TLANDO may be too small to detect but can still increase the risk for MACE.

Before initiating TLANDO, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled. Check BP approximately 3 weeks after initiating TLANDO and periodically thereafter. Treat new-onset hypertension or exacerbations of pre-existing hypertension. Re-evaluate whether the benefits of continued treatment with TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease.

Polycythemia: Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. Check hematocrit prior to initiating TLANDO. Evaluate hematocrit approximately every 3 months during the first year of treatment, and then every 6 months thereafter while the patient is taking TLANDO. If hematocrit becomes elevated, stop TLANDO until hematocrit decreases to an acceptable concentration. If TLANDO is restarted and again causes hematocrit to become elevated, stop TLANDO permanently. An increase in red blood cell mass may increase the risk of thromboembolic events.

Cardiovascular Risk: Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men.

TLANDO can cause BP increases that can increase the risk of MACE. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO.

Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms. Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer, including measurement of prostate specific antigen (PSA), prior to initiating and during treatment with androgens.

Venous Thromboembolism: There have been post marketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacement products such as TLANDO. Evaluate patients who report symptoms of pain, edema, warmth, and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue TLANDO and initiate appropriate workup and management.

Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations: Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions.

If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.

Not for Use in Women: Due to lack of controlled studies in women and the potential for virilizing effects, TLANDO is not indicated for use in women. Potential for Adverse Effects on Spermatogenesis: With large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) possibly leading to adverse effects on semen parameters including sperm count. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO.

Hepatic Adverse Effects: Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. TLANDO is not a 17 alpha-alkyl androgen and is not known to produce hepatic adverse effects associated with 17-alpha-alkyl androgens.

Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue TLANDO while the cause is evaluated.

Edema: Androgens, including TLANDO, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease [see Adverse Reactions (6.1)]. In addition to discontinuation of the drug, appropriate work up and management of edema may be required.

Sleep Apnea: The treatment of hypogonadal men with testosterone products may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.

Gynecomastia: Gynecomastia may develop and persist in patients being treated for hypogonadism.

Lipid Changes: Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically after starting testosterone therapy.

Hypercalcemia: Androgens, including TLANDO, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Monitor serum calcium concentrations periodically in these patients.

Decreased Thyroxine-binding Globulin: Androgens, including TLANDO, may decrease concentrations of thyroxin-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of triiodothyronine (T3) and thyroxine (T4). Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Increases in Prolactin: Increases in serum prolactin have been reported in patients treated with TLANDO in clinical trials. Evaluate serum prolactin levels prior to initiating treatment with TLANDO. Re-evaluate serum prolactin levels 3 to 4 months after starting treatment. If serum prolactin remains elevated, discontinue TLANDO.

ADVERSE REACTIONS

The safety of TLANDO was evaluated in 2 clinical studies in a total of 233 men.

Study 18-001: 138 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 4 months.

Study 16-002: 95 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 24 days.

The most commonly reported adverse reactions ( 2%) were: increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain.

DRUG INTERACTIONS

Insulin: Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

Oral Anticoagulants: Changes in anticoagulant activity may be seen with androgens. Frequent monitoring of INR and prothrombin time may be necessary in patients taking anticoagulants, especially at the initiation and termination of androgen therapy.

Corticosteroids: The concurrent use of testosterone with corticosteroids may result in increased fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal or hepatic disease.

Drugs that May Also Increase Blood Pressure: Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. Concomitant administration of these medications with TLANDO may lead to additional increases in blood pressure.

USE IN SPECIFIC POPULATIONS

Pregnancy: TLANDO is contraindicated in pregnant women and not indicated for use in females. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies (see Data) and its mechanism of action. Exposure of a female fetus to androgens may result in varying degrees of virilization. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies. Lactation: TLANDO is not indicated for use in females.

Females and Males of Reproductive Potential: During treatment with large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis. Reduced fertility is observed in some men taking testosterone replacement therapy. The impact on fertility may be irreversible. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids.

Pediatric Use: The safety and effectiveness of TLANDO in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.

Geriatric Use: There have not been sufficient numbers of geriatric patients in controlled clinical studies with TLANDO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. Of the 95 patients enrolled in Study 16-002, the 24-day major safety and effectiveness study utilizing TLANDO, 16 (16.8%) were over 65 years of age. Additionally, there is insufficient long-term safety data in geriatric patients utilizing TLANDO to assess the potentially increased risk of cardiovascular disease and prostate cancer.

Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension.

DRUG ABUSE AND DEPENDENCE

TLANDO contains testosterone undecanoate, a Schedule III controlled substance.

Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids may be abused by athletes and bodybuilders.

Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression.

The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.

The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.

The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.

Withdrawal symptoms can be experienced upon abrupt discontinuation in patients with addiction. Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Drug dependence in individuals using approved doses for approved indications has not been documented.

For more information, call 1-844-996-7833.

Please see full Prescribing Information, including Boxed Warning and Medication Guide.

About TLANDO XR

TLANDO XR (also known as LPCN 1111) is a next-generation, novel ester prodrug of testosterone comprised of testosterone tridecanoate (TT) which uses Lipocine's proprietary delivery technology to enhance solubility and improve systemic absorption. Lipocine has successfully completed a Phase2bdose finding study in hypogonadal men. Results suggested that the primary objectives were met, including identifying the dose expected to be tested in a planned Phase 3 study that would be required for FDA approval.

About Verity Pharma

Verity Pharma is a specialty pharmaceutical company focused on delivering meaningful solutions to healthcare professionals and their patients.

Verity Pharma works with best-in-class global pharmaceutical manufacturing partners to ensure that product quality and availability is a constant deliverable. The company is also committed to supporting programs, initiatives, and organizations that help improve health, expand research opportunities and promote education within the healthcare community. Learn more atwww.veritypharma.com.

About Lipocine

Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products for CNS disorders. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnering. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs.

Lipocine's clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN1154, for rapid relief of postpartum depression, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of non-cirrhotic NASH. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, pleasevisitwww.lipocine.com.

Forward-Looking Statements

This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Verity Pharma's development and commercialization of TLANDO and TLANDO XR, the amount of the license fee, milestone payments, and royalty payments we will ultimately receive, Verity Pharma's ability to grow the TLANDO franchise, our product development efforts, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, our development of and filing of a NDA with the FDA for LPCN 1148, and the potential uses and benefits of our product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates to treat CNS disorders, we may not have sufficient capital to complete the development processes for our product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website atwww.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-continued-commercialization-of-tlando-through-verity-pharmaceuticals-302050012.html

SOURCE Lipocine Inc.

Continue reading here:
Lipocine Announces Continued Commercialization of TLANDO through Verity Pharmaceuticals - BioSpace

Read More..

Jan 11

Ikaria Gummies for Weight Loss 2024 – Best Weight Reduction gummies – Deccan Herald

Ikaria Gummies is a powerful supplement for losing weight because it is made from natural ingredients of the highest quality. Besides helping with weight loss and the treatment of fatty liver disease, this powder supplement also improves kidney function, heart function, and digestive function.

However, the need for weight loss has never been higher. People want to achieve healthy fat loss without giving up too much time and effort, because of the many health problems related to obesity. But how can they reach their goals without the time to focus on a healthy lifestyle and diet?

>>>>>>>>> Click Here Visit (Ikaria Gummies) Official Website <<<<<<<<<

With the help of Ikaria Gummies, you can naturally restore your health and shed extra pounds. There are many different products available that can help with this goal. The only challenge is choosing the best option for you.

A proper supplement should boost fat burning naturally, without interfering with other essential functions of your body.

From avoiding long-term diets to skipping the gym, this article examines an all-natural supplement that has helped countless people reach their weight loss goals.

Ikaria Gummies for Weight Loss is an advanced weight management formula that has been designed to support healthy fat loss with the help of scientifically proven ingredients. Lets explore the details of Ikaria Gummies for Weight Loss in this comprehensive review.

Are you someone who is looking for a reliable piece of Ikaria Gummies review? Then you have come to the right place. Well, I have been a professional nutritionist for the past 10 years. Recently I learned about the Ikaria Gummies and I decided to research what it is. There were many reviews but nothing felt trustworthy. But my independent study and reading about Ikaria Gummies powder helped me find some facts about it. I want to share those with you. I am sure that this review will be very helpful for you to find the validity of the product.

>>>>>>>>> Click Here Visit (Ikaria Gummies) Official Website <<<<<<<<<

Get ready to dive into a thorough review of Ikaria Gummies, where well navigate the ins and outs to determine if this dietary supplement is a real solution or possibly a scam. In a market flooded with weight loss products, its important to distinguish the genuine from the doubtful. Our analysis will carefully examine Ikaria Gummies, focusing on its ingredients, claimed benefits, and user experiences, all in the quest of shedding light on its legitimacy.

Health is a true treasure for every human being. It is a gift that is given by God. If you want to live an active, healthy, and strong life to enjoy every moment and occasion, you need to be healthy. If all your efforts to get a slim and smart body failed, now you should try Ikaria Gummies for Weight Loss to get desired results. This wonderful supplement helps you to lower your weight within three months without doing any hard exercise and you dont need to follow any diet plan.

This supplement helps you to energise and maintain your body. If you use it daily, you will get amazing results. This product is made for people who want to lower their weight fast and without any harmful effects. It is a new weight loss invention that provides incredible results to its customers at a low price. It is a natural and herbal weight-reducing product. It gives a pleasing body shape to its users.

Read more:
Ikaria Gummies for Weight Loss 2024 - Best Weight Reduction gummies - Deccan Herald

Read More..

Contact Us Today


    Your Full Name

    Your Email

    Your Phone Number

    Select your age (30+ only)

    Select Your US State

    Program Choice

    Confirm over 30 years old

    Yes

    Confirm that you resident in USA

    Yes

    This is a Serious Inquiry

    Yes

    Message:



    matomo tracker