Testosterone undecanoate

Hypogonadism Market Spotlight Report 2021: Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-specific Revenue Forecasts - ResearchAndMarkets.com

Retrieved on: 
Thursday, January 27, 2022

This Market Spotlight report covers the Hypogonadism market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, key upcoming and regulatory events, probability of success, patent information, epidemiology, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Points: 
  • This Market Spotlight report covers the Hypogonadism market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, key upcoming and regulatory events, probability of success, patent information, epidemiology, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
  • The approved drugs in the hypogonadism space target androgen receptors, estrogen receptor alpha, and estrogen receptor beta.
  • There are almost equal proportions of clinical trials for hypogonadism across Phase I-IV, with 51% in Phase I-II, and 49% in Phase III-IV.
  • AbbVie leads industry sponsors with the highest overall number of clinical trials for hypogonadism, followed by GlaxoSmithKline.

Lipocine To Present At The Ladenburg Thalmann Healthcare Conference

Retrieved on: 
Tuesday, July 6, 2021

SALT LAKE CITY, July 6, 2021 /PRNewswire/ --Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the Ladenburg Thalmann Healthcare Conference.

Key Points: 
  • SALT LAKE CITY, July 6, 2021 /PRNewswire/ --Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the Ladenburg Thalmann Healthcare Conference.
  • The webcast of this presentation will also be available on Lipocine's corporate website under "Events & Presentations" in the Investors section.
  • Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies.
  • TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing.

Marius Announces Ambulatory Blood Pressure Results Published in the Journal of Clinical Hypertension with their new testosterone medication KYZATREX™

Retrieved on: 
Friday, June 11, 2021

Effects of Oral Testosterone Undecanoate KYZATREX on Ambulatory Blood Pressure in Hypogonadal Men was published by William B.

Key Points: 
  • Effects of Oral Testosterone Undecanoate KYZATREX on Ambulatory Blood Pressure in Hypogonadal Men was published by William B.
  • The publication of these results marks a significant milestone in the field of testosterone therapy as ambulatory blood pressure monitoring (ABPM) is the most accurate means to detect small BP changes in clinical trials and practice.
  • commented, The changes in ambulatory BP were quite minimal in our study and of no clinical significance in normotensive men, a first in the testosterone space.
  • Shalin Shah, Co-CEO of Marius commented, We are extremely proud of the blood pressure data produced across all patient groups.

Lipocine Announces Publication in Journal of Endocrinological Investigation Highlighting the Potential of LPCN 1144 in the Treatment of NASH and Hepatic Fibrosis

Retrieved on: 
Thursday, March 4, 2021

The results were featured in a paper entitled "Treatment Potential ofLPCN 1144 onLiver Health andMetabolic Regulation inaNonGenomic, High Fat Diet Induced NASH Rabbit Model" (Comeglio et al), published in the Journal of Endocrinological Investigation ( https://doi.org/10.1007/s40618-021-01522-7 ).

Key Points: 
  • The results were featured in a paper entitled "Treatment Potential ofLPCN 1144 onLiver Health andMetabolic Regulation inaNonGenomic, High Fat Diet Induced NASH Rabbit Model" (Comeglio et al), published in the Journal of Endocrinological Investigation ( https://doi.org/10.1007/s40618-021-01522-7 ).
  • Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies.
  • Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107.
  • TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing.

Lipocine Announces Presentations on TLANDO™ at ENDO 2021 Conference

Retrieved on: 
Wednesday, March 3, 2021

Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107.

Key Points: 
  • Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107.
  • TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing.
  • In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points.
  • Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

Lipocine to Present at Two Upcoming Investor Conferences

Retrieved on: 
Friday, February 26, 2021

The webcasts of these presentations will also be available on Lipocine's corporate website under "Events & Presentations" in the Investors section.

Key Points: 
  • The webcasts of these presentations will also be available on Lipocine's corporate website under "Events & Presentations" in the Investors section.
  • Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies.
  • Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107.
  • TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing.

Lipocine to Present at the H.C. Wainwright BioConnect 2021 Conference

Retrieved on: 
Monday, January 4, 2021

The webcast will be available on the Lipocine's website for 90 days.

Key Points: 
  • The webcast will be available on the Lipocine's website for 90 days.
  • Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies.
  • Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107.
  • TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing.

Lipocine Announces Update on Jury Trial in Patent Infringement Lawsuit Against Clarus Therapeutics

Retrieved on: 
Tuesday, December 29, 2020

The jury trial will be rescheduled once it becomes clear when jury trials will resume in the District of Delaware.

Key Points: 
  • The jury trial will be rescheduled once it becomes clear when jury trials will resume in the District of Delaware.
  • In the pending suit against Clarus Therapeutics, Inc. ("Clarus") Lipocine isalleging that Clarus's JATENZO product infringes Lipocine's U.S. patents: 9,034,858; 9,205,057; 9,480,690; and 9,757,390.
  • Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies.
  • Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

Lipocine Provides Regulatory Update on TLANDO™

Retrieved on: 
Friday, November 6, 2020

Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies.

Key Points: 
  • Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies.
  • Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107.
  • Lipocine has resubmitted its NDA to the FDA for TLANDO and it is currently under review by the FDA.
  • TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing.

Lipocine to Present at the H.C. Wainwright 4th Annual NASH Investor Conference

Retrieved on: 
Tuesday, September 29, 2020

Lipocine's clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107.

Key Points: 
  • Lipocine's clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107.
  • TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men.
  • Lipocine has resubmitted its NDA to the FDA for TLANDO and is awaiting FDA decision on its NDA.
  • LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH.