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Details:
Prime (testosterone undecanoate) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Prime
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 12, 2024
Details:
Verity will market TLANDO (testosterone undecanoate), the first and only oral testosterone replacement therapy in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone, in the United States and, if approved, in Canada.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Tlando
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Verity Pharmaceuticals Inc
Deal Size: $270.0 million Upfront Cash: $2.5 million
Deal Type: Licensing Agreement February 02, 2024
Details:
Under the agreement, Verity Pharma will market Tlando (testosterone undecanoate), the first and only oral testosterone replacement therapy (TRT), in the United States and, if approved, in Canada.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Tlando
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Verity Pharmaceuticals Inc
Deal Size: $270.0 million Upfront Cash: $2.5 million
Deal Type: Licensing Agreement January 18, 2024
Details:
Kyzatrex (testosterone undecanoate) is a proprietary oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: KYZATREX
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 09, 2024
Details:
KYZATREX™ (testosterone undecanoate) is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Kyzatrex
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2023
Details:
The partnership aims at addressing the pressing global issue of hypogonadism through the launch of a comprehensive Early Access Program for Kyzatrex (testosterone undecanoate), a proprietary softgel oral formulation absorbed primarily via the lymphatic system.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Kyzatrex
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Marius Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership August 10, 2023
Details:
Nebido (having testosterone undecanoate) is the only available injectable long-acting depot preparation of testosterone undecanoate, developed for the treatment of male hypogonadism.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Nebido
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Grunenthal
Deal Size: $498.1 million Upfront Cash: Undisclosed
Deal Type: Acquisition November 02, 2022
Details:
Following a competitive auction process, Tolmar was selected as the winning bidder in the sale of JATENZO (testosterone undecanoate), and the sale was approved by the U.S. Bankruptcy Court for the District of Delaware.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Jatenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Tolmar
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition October 27, 2022
Details:
JATENZO (testosterone undecanoate) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Jatenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2022
Details:
JATENZO (testosterone undecanoate capsules; C-III), is the most prescribed FDA-approved softgel treatment with a safe delivery to help reach and keep normal testosterone levels.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Jatenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2022
Details:
KYZATREX™ (testosterone undecanoate) is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Kyzatrex
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2022
Details:
KYZATREX™ is an oral testosterone replacement therapy ("TRT") indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Kyzatrex
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 02, 2022
Details:
JATENZO is the first and only FDA-approved oral softgel for testosterone replacement therapy in adult males who have deficient testosterone due to certain medical conditions.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Jatenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2022
Details:
Nebido (testosterone undecanoate) is used for male hypogonadism. It is used for treating clinical symptoms such as regression of secondary sexual characteristics, change in body composition, asthenia, reduced libido or erectile dysfunction due to low testosterone levels.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Nebido
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Grunenthal
Deal Size: $506.6 million Upfront Cash: Undisclosed
Deal Type: Acquisition July 14, 2022
Details:
JATENZO (testosterone undecanoate) is the first FDA-approved oral softgel for testosterone replacement therapy in adult males who have deficient testosterone due to certain medical conditions.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Jatenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2022
Details:
TLANDO (testosterone undecanoate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Tlando
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2022
Details:
Halozyme and Antares will create a drug delivery and specialty product company. The Antares business consists of a best-in-class, auto injector and ENHANZE platform that offers broad licensing opportunity, with 3 commercial products including Tlando (testosterone undecanoate).
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Tlando
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Halozyme Therapeutics
Deal Size: $960.0 million Upfront Cash: $960.0 million
Deal Type: Acquisition May 24, 2022
Details:
CLAR-121 is combination of testosterone undecanoate (natural ligand for the androgen receptor and anastrozole delivered by a subcutaneous implant for treatment of AR-mediated inflammatory breast disease that predominantly affects women.
Lead Product(s): Testosterone Undecanoate,Anastrozole
Therapeutic Area: Immunology Product Name: CLAR-121
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2022
Details:
Jatenzo (testosterone undecanoate), is the first FDA-approved oral softgel for testosterone replacement therapy in adult males who have deficient testosterone due to certain medical conditions.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Jatenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 09, 2022
Details:
JATENZO (testosterone undecanoate) is the first FDA-approved oral softgel for testosterone replacement therapy in adult males who have deficient testosterone due to certain medical conditions.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Jatenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
Details:
TLANDO® is an oral treatment for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone in adult males.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Tlando
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Antares Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 25, 2022
Details:
Jatenzo (testosterone undecanoate) is the first FDA-approved oral softgel for testosterone replacement therapy in adult males who have deficient testosterone due to certain medical conditions.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Jatenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2022
Details:
The combination of Halozyme and Antares will create a drug delivery and specialty product company. The Antares business consists of a best-in-class, auto injector and ENHANZE platform that offers broad licensing opportunity, with 3 commercial products including Tlando.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Tlando
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Halozyme Therapeutics
Deal Size: $960.0 million Upfront Cash: $960.0 million
Deal Type: Acquisition April 13, 2022
Details:
TLANDO ® (testosterone undecanoate), an oral treatment for testosterone replacement therapy (“TRT”) indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Tlando
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Lipocine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2022
Details:
JATENZO (testosterone undecanoate) is the first and only FDA-approved oral softgel for testosterone (T) replacement therapy in adult males who have deficient T due to certain medical conditions, for the treatment of adult hypogonadal men with chronic kidney disease.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Jatenzo
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2022
Details:
Clarus intends to use the net proceeds from the private placement to support growth initiatives for its near-term commercial objectives for its oral testosterone replacement product, JATENZO.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Jatenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cantor Fitzgerald & Co.
Deal Size: $15.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement December 07, 2021
Details:
Clarus intends to use the net proceeds from the private placement to support growth initiatives for its near-term commercial objectives for its oral testosterone replacement product, JATENZO.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Jatenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cantor Fitzgerald & Co.
Deal Size: $15.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement December 03, 2021
Details:
In granting tentative approval, the FDA concluded that TLANDO® met all required efficacy, quality and safety standards necessary for approval and will be eligible for final approval and marketing in the U.S.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Tlando
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Antares Pharma
Deal Size: $25.0 million Upfront Cash: $11.0 million
Deal Type: Licensing Agreement October 18, 2021
Details:
JATENZO® (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Jatenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2021
Details:
Both LPCN 1144 treatment arms met with statistical significance the pre-specified histology based regulatory endpoint of NASH resolution with no worsening of fibrosis.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: LPCN 1144
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2021
Details:
Transaction will accelerate commercialization of JATENZO®, the market-leading oral testosterone replacement therapy, and fund expansion of the company’s pipeline of androgen and metabolic therapies for men and women, including orphan indications.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Jatenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Clarus Therapeutics
Deal Size: $379.0 million Upfront Cash: Undisclosed
Deal Type: Merger April 27, 2021
Details:
KYZATREX®, an oral testosterone undecanoate softgel, had one of the most comprehensive Phase 3 trials in the testosterone space and if approved, has the potential to be the only first-action approval oral testosterone product on the market.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Kyzatrex
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2021
Details:
KYZATREX® has generated strong results in both safety and efficacy studies for KYZATREX® for treatment of primary and secondary hypogonadism in men.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Kyzatrex
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 05, 2021
Details:
Company will present a poster with results from a preclinical study investigating LPCN 1144 treatment on hepatic fibrosis and non-alcoholic steatohepatitis features at The Liver Meeting Digital Experience™, hosted by the American Association for the Study of Liver Diseases.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: LPCN 1144
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
Details:
Results from the previously completed dose validation ("DV") study of a fixed dose TLANDO in hypogonadal males will also be presented at the meeting.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Tlando
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2020
Details:
The LiFT Phase 2 clinical study is a 38-week, prospective, multi-center, randomized, double-blind, placebo-controlled, three-arm study of LPCN 1144 in biopsy-confirmed male NASH subjects (based on NAFLD activity score) with grade F1-F3 fibrosis.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: LPCN 1144
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020
Details:
U.S. Food and Drug Administration ("FDA") has informed the Company that it needs additional time to complete its review of TLANDO’s New Drug Application ("NDA") and is committed to taking action as expeditiously as possible.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Tlando
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 28, 2020
Details:
Treatment with LPCN 1144 (oral T prodrug) in hypogonadal males with NAFLD resolved NAFLD in approximately half of the affected patients without any safety signals.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: LPCN 1144
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2020
Details:
Clinical data for lead candidate TLANDO™ will be presented at the American Urological Association Virtual Conference. TLANDO is an oral testosterone replacement therapy product candidate for adult males with hypogonadism.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2020
Details:
Clarus originally filed the Citizens Petition with the FDA requesting the FDA issue "clear, written guidance regarding the safety and efficacy standards for oral testosterone-ester prodrugs.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 17, 2020
Details:
The FDA requested that the information generated by the reanalysis be submitted as part of an NDA resubmission with a six-month Prescription Drug User Fee Act clock.
Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2020
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