Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Theratechnologies Receives Complete Response Letter from FDA for F8 Tesamorelin sBLA
Details : Egrifta (tesamorelin) is a growth hormone releasing factor (GRF) analog used to reduce excessive abdominal fat in HIV patients who have developed lipodystrophy.
Brand Name : Egrifta
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 24, 2024
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Theratechnologies Receives FDA Update on Tesamorelin F8 Biologics License Application
Details : Egrifta (tesamorelin) is a growth hormone releasing factor (GRF) analog used to reduce excessive abdominal fat in HIV patients who have developed lipodystrophy.
Brand Name : Egrifta
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 23, 2024
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Theratechnologies Receives January 2024 PDUFA Goal Date for Tesamorelin F8 Formulation sBLA
Details : EGRIFTA F8® (tesamorelin for injection) is approved in the United States and indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.
Brand Name : Egrifta MDV
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 04, 2023
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Dermatology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Theratechnologies Submits Tesamorelin F8 Formulation sBLA for FDA Review
Details : EGRIFTA F8® (tesamorelin for injection) is approved in the United States and indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.
Brand Name : Egrifta F8
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 25, 2023
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Dermatology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : TH9507 (tesamorelin) stimulates growth hormone secretion (GHRH), and subsequently increases IGF-1 and IGFBP-3 levels. GHRH is indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
Brand Name : EGRIFTA SV
Molecule Type : Peptide
Upfront Cash : Not Applicable
February 22, 2023
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Dermatology
Study Phase : Approved
Sponsor : World Orphan Drug Alliance
Deal Size : Undisclosed
Deal Type : Agreement
Details : EGRIFTA SV® (tesamorelin for injection) is approved in the United States and indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.
Brand Name : Egrifta SV
Molecule Type : Large molecule
Upfront Cash : Undisclosed
January 05, 2023
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Dermatology
Highest Development Status : Approved
Sponsor : World Orphan Drug Alliance
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Dermatology
Study Phase : Approved
Sponsor : Marathon Asset Management
Deal Size : Undisclosed
Deal Type : Financing
Details : The priorities include the advancement of the clinical oncology pipeline, which is currently in a larger Phase 1b basket study, and the rapid growth of our existing marketed brands, EGRIFTA SV® and Trogarzo®.
Brand Name : Egrifta SV
Molecule Type : Peptide
Upfront Cash : Undisclosed
July 13, 2022
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Dermatology
Highest Development Status : Approved
Sponsor : Marathon Asset Management
Deal Size : Undisclosed
Deal Type : Financing
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Theratechnologies Provides Update on Its Planned Phase 3 Clinical Trial in NASH
Details : The Phase 3 clinical trial will be a multicenter, double-blind, placebo-controlled two-part study to evaluate the safety and efficacy of tesamorelin in liver-biopsy confirmed patients with NAS score of at least 4 and stage 2 or 3 fibrosis.
Brand Name : Egrifta
Molecule Type : Peptide
Upfront Cash : Not Applicable
July 15, 2021
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Oral presentation includes data on the mechanism of effect of tesamorelin in nonalcoholic fatty liver disease (NAFLD) will be given by Lindsay T Fourman at The Liver Meeting® 2020 of the American Association for the Study of Liver Diseases (AASLD).
Brand Name : Tesamorelin F8
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 06, 2020
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The company is also plan on filing patent applications in other jurisdictions to expand our protection of tesamorelin.
Brand Name : F8
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 13, 2020
Lead Product(s) : Tesamorelin Acetate
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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