Tlando (testosterone undecanoate) / Lipocine - LARVOL DELTA

Lipocine partner files for Canadian approval of oral TRT drug (Investing.com) - "Lipocine Inc...has announced that its licensing partner, Verity Pharma, has submitted a New Drug Submission (NDS) in Canada for TLANDO, an oral testosterone replacement therapy (TRT). TLANDO is already approved by the US Food and Drug Administration (FDA) and is notable for not requiring dose titration."

Canada filing • Endocrine Disorders

Changes in Blood Test Profiles with Use of Testosterone Undecanoate Capsules (TLANDO) in Men with Hypogonadism (AUA 2025) - "Our initial experience with TLANDO TU capsules for the treatment of hypogonadism shows it is safe and efficacious with unique post treatment blood test changes, including a decrease in SHBG in both groups."

Acne Vulgaris • Alopecia • Endocrine Disorders • Hypertension

Newer formulations of oral testosterone undecanoate: development and liver side effects. (PubMed, Sex Med Rev) - "Continued research into the safety of oral TU will contribute to a better understanding of the potential risks in patients receiving this therapy, an outcome that highlights the importance of providing patient education and reassurance regarding oral TU safety."

Adverse events • Journal • Hepatology • Liver Failure

Safety, efficacy, and pharmacokinetics of oral testosterone undecanoate in males with hypogonadism. (PubMed, Andrology) - P3 | "Male patients with hypogonadism receiving oral testosterone undecanoate 225 mg twice daily demonstrated improvements in libido and sexual frequency. Serum testosterone concentrations were within the reference range in 87% of patients without dose titration."

Journal • PK/PD data • Endocrine Disorders

A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial (clinicaltrials.gov) - P2 | N=25 | Completed | Sponsor: Lipocine Inc. | Active, not recruiting ➔ Completed

Trial completion • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

[VIRTUAL] Clinical Experience with TLANDO in Hypogonadal Men (AUA 2021) - P3 | "Safe and effective T restoration post TLANDO treatment without titration requirement was confirmed including older hypogonadal men. Single strength/dose with no titration requirement may result in improved patient compliance. Upon approval, TLANDO will uniquely enabling selection of the efficacious dose from the start of therapy."

Clinical • Hepatology • Liver Failure

Monitoring Testosterone (T) Levels in Men Receiving Oral Testosterone Undecanoate (TU): Dealing with Post-Collection Conversion of TU to T (AUA 2019) - "Post-collection conversion of TU to T can cause overestimation of circulating T levels in men dosed with oral TU. By accounting for the conversion with different tube types / handling conditions, a conversion factor was derived such that T concentrations in our oral TU patients can be monitored using serum T levels. This conversion factor was validated using inTUne data."

Testosterone Replacement Therapy: A Narrative Review with a Focus on New Oral Formulations. (PubMed, touchREV Endocrinol) - "Based on unique chemistry using a self-emulsifying drug delivery system and lymphatic absorption, JATENZO and TLANDO address some of the limitations of other dosing routes while providing a safe option without evidence of liver dysfunction. This review discusses various testosterone treatment options, focusing on the role and pharmacokinetics of the new oral formulations."

Journal • Review • Endocrine Disorders • Hepatology • Liver Failure

Non-Titratable Fixed-Dose Oral Testosterone Undecanoate (TLANDO) Restores Testosterone to Eugonadal Ranges (WSAUA 2022) - P3 | "CONCLUSIONS This comparison between fixed-dose and dose-adjusted patients demonstrated that oral TU titration has minimal impact on PK profiles. Fixed-dose oral TU was well-tolerated and restored testosterone to eugonadal ranges in male patients with testosterone deficiency."

Two new oral testosterone products for hypogonadism. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Endocrine Disorders

A new oral testosterone (TLANDO ) treatment regimen without dose titration requirement for male hypogonadism. (PubMed, Andrology) - P3 | "TLANDO restored T levels to the normal range in the majority of hypogonadal males. This new oral TRT can provide an option for no-titration oral TRT. This therapy has the potential to improve patient compliance in TRT."

Clinical • Journal • Endocrine Disorders

Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD4 • CD8 • FOXP3

"$ATRS Antares Pharma Announces FDA Acceptance of NDA Resubmission for TLANDO® https://t.co/ZMQhlflxOg" (@stock_titan)

FDA event • NDA

"$LPCN Lipocine Announces FDA Affirmation Of Class 1 NDA Resubmission For TLANDO® https://t.co/nZrSG8QtPe" (@stock_titan)

NDA

JATENZO®: Challenges in the development of oral testosterone. (PubMed, Int J Impot Res) - "Recently, JATENZO® (testosterone undecanoate) oral capsules was approved by the US FDA as an oral option for men suffering from TD. In this article, we will discuss the history and challenges in the development of a viable oral formulation of exogeneous TT and examine how JATENZO® addresses these concerns."

Journal • Review • Hepatology

Patient Satisfaction After Switching to Oral Testosterone Undecanoate (clinicaltrials.gov) - P4; N=40; Recruiting; Sponsor: University of Miami

New P4 trial

Effects of a Novel Oral Testosterone Undecanoate on Ambulatory Blood Pressure in Hypogonadal Men. (PubMed, J Cardiovasc Pharmacol Ther) - P3 | "Hence, hematocrit may aid in predicting the development of BP increases on testosterone therapy. NCT03868059."

Journal • Endocrine Disorders • Hematological Disorders • Hypertension

Effects of the oral testosterone undecanoate Kyzatrex™ on ambulatory blood pressure in hypogonadal men. (PubMed, J Clin Hypertens (Greenwich)) - "These data demonstrate small increases in ambulatory BP following 120 days on this oral testosterone undecanoate with no further changes at 180 days. Changes in ambulatory BP were minimal in patients not taking antihypertensive therapy."

Journal • Endocrine Disorders • Hypertension

[VIRTUAL] Safety Analysis of an Oral Testosterone Undecanoate (TU) Formulation Following 2 Years of Administration in Hypogonadal Men (AACE 2021) - "Until recently, the only oral TRT approved in the US was methyl-T which has been associated with hepatotoxicity. The safety of a novel oral T undecanoate (TU) formulation was evaluated in hypogonadal men for up to 2 years."

Clinical • Hepatology

[VIRTUAL] Safety Analysis of an Oral Testosterone Undecanoate (TU) Formulation Following 2 Years of Administration in Hypogonadal Men (AACE 2021) - "This oral TU formulation is an effective long-term therapy for hypogonadal men and has a safety profile consistent with other approved T products. Notably, no evidence of liver toxicity was observed. The long-term efficacy and safety profile of oral TU may provide a treatment option that avoids issues associated with other TRTs, such as injection site pain or transference to partners and children."

Clinical • Hepatology • Pain

[VIRTUAL] A Novel Oral Testosterone Therapy (TLANDO) Safely Restores Testosterone to Eugonadal Levels with Fixed Dose Treatment (ENDO-I 2020) - P3 | "TLANDO (LPCN 1021) is a novel oral testosterone undecanoate (TU) product absorbed via the intestinal lymphatic pathway...Overall mean treatment compliance was 99.7 ± 4.9%. In conclusion, a twice-daily, fixed-dose of TLANDO (450 mg TU total daily dose) successfully achieved target serum T level and achieved a safety profile consistent with that of other approved TRT products."

Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain

[VIRTUAL] Effects of A New Oral Testosterone Undecanoate (TLANDO) Therapy on Liver (AUA 2020) - "Contrary to hepatotoxic experience with MT, these clinical results suggest that TLANDO (a lymphatically delivered oral testosterone) has no adverse effects on liver. It may be suitable for prolonged use as demonstrated by substantial reductions of elevated liver enzymes and meaningful reductions in abnormal accumulated liver fat. Source of Funding: Lipocine Inc."

Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Obesity • MRI

[VIRTUAL] TLANDO, a Novel Oral TRT, Improves Sexual and Mental Domain Outcomes in Hypogonadal Men (ENDO 2021) - P3 | "For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021."

Hepatology

[VIRTUAL] Efficacy and Safety of TLANDO, A Novel Oral Easy to Prescribe and Use TRT Option (ENDO 2021) - P3 | "For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021."

Clinical • Infectious Disease • Novel Coronavirus Disease

Effects of Long-Acting Testosterone Undecanoate on Behavioral Parameters and Na + , K-ATPase mRNA Expression in Mice with Alzheimer`s Disease. (PubMed, Neurochem Res) - "In most cases, altered gene expression was significant and correlated with the observed behavioral changes. Taken together, our findings provide new insight into the effects of long-acting testosterone undecanoate administration on locomotor activity, long-term memory, anxiety, and spatial memory in male mice with Alzheimer's disease."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Depression • Mood Disorders • Psychiatry