Triptorelin is a luteinizing hormone releasing hormone (LHRH) agonist
Triptorelin the active substance of Decapeptyl®/Trelstar®/Pamorelin®, is a GnRH agonist analogue. An agonist is a chemical that binds to a receptor of a cell and triggers a response by that cell. Triptorelin decreases the serum testosterone to castrate levels. Androgen deprivation stops the growth of the androgen dependent prostate cancer, alleviating pain and improving thus the quality of life of patients. GnRH agonist treatment achieves similar overall survival rates in advanced prostate cancer as surgical castration. A survival benefit has been shown in locally advanced prostate cancer when androgen deprivation therapy was given in combination with radiotherapy: 79% of patients survived for 5 years, whilst only 62% of patients treated with radio-therapy alone survived for the same duration of 5 years.
The triptorelin 1-month, 3-month and 6-month sustained release formulations have provided patients with a convenient treatment modality, enabling an enhanced compliance.
Current status
- Number 1 product of Ipsen
- Indications: advanced prostate cancer, endometriosis, precocious puberty, in-vitro fertilisation programs, uterine fibroids
- Licensees: Ipsen (Pamorelin® and Pamorelin® LA ), Watson (Trelstar® Depot & Trelstar® LA), Ferring (Decapeptyl® Depot) , Tecnofarma (Decapeptyl®), Aché (Neo-Decapeptyl ®), Rowfarma (Pamorelin®) and Sidus (Decapeptyl Retard®)
- Current licensee sales in excess of $400M
Decapeptyl®, Trelstar® history
Licensed-in
In 1982 from Tulane University. It had previously been abandoned by several pharmaceutical companies.
Status at in-licensing
Late preclinical phase
Debiopharm value added
- Development and registration of the triptorelin 1-, 3- and 6-month sustained release formulations in Europe and the United States
- First worldwide sustained release formulation of a luteinizing hormone releasing hormone (LHRH) agonist
- Developed a new salt, storage at room temperature, extended patent life
- Continuous life cycle management (LCM) (6 month formulations, new injection devices, new indications and new territories)
Timeline
- First approval of the triptorelin 1-month acetate formulation in 1986, in France
The timelines below concern the triptorelin pamoate formulation
- Approval of the 1- month formulation in Switzerland in 1998
- The US FDA approves the 1-month formulation in 2000
- The US FDA approves the 3-month-formulation in 2001
- First national approval in Europe for the 1-month formulation in 2001
- First national approval in Europe for the 3-month formulation in 2004
- First national approval in Europe for the 6-month formulation in 2009
- The US FDA approves the 6-month formulation in 2010
- Approval of the 3-month formulation in Switzerland in 2005
