drugset

Drugs / Debio 4326

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Debio 4326

also known as Triptorelin

Developed for: central precocious puberty
Investigated by: Debiopharm International SA

Trials 1

today NCT06129539 · Ph 3

20252026

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 3	NCT06129539	Jul 2024 → Oct 2026 expected	central precocious puberty	Debiopharm International SA	Active not recruiting	No outcome recorded

News releases announcing trial results or a regulatory action · 2

Date	Issuer	Release
2009-07-21	Debiopharm International SA	Regulatory Swissmedic grants Debiopharm marketing authorisation for Moapar® – A new therapeutic avenue for the treatment of sexual deviations debiopharm.com ↗
2006-06-20	Debiopharm International SA	Regulatory Moapar® 3-months approved for the lowering of testosterone to castrate serum levels for control of sexual drive in adult men debiopharm.com ↗

All press releases naming this drug 17 releases

Date	Issuer	Release
2025-11-06	Debiopharm International SA	Debiopharm Takes a Step Forward for Children with CPP: Enrollment Completion for the Phase III Trial Evaluating the First Ever Yearly Injectable Triptorelin Formulation debiopharm.com ↗
2024-09-09	Debiopharm International SA	First Patients Dosed in Debiopharm’s Phase III Trial (LIBELULA) Investigating Debio4326, A 12-Month Triptorelin Formulation for Children with Central Precocious Puberty debiopharm.com ↗
2021-10-07	Debiopharm International SA	Debiopharm & Dexa Medica Launch Triptorelin Collaboration to Bring New Hope To Women With Endometriosis debiopharm.com ↗
2019-06-12	Debiopharm International SA	Debiopharm and Ipsen extend their strategic Decapeptyl® (triptorelin) partnership for another 15 years debiopharm.com ↗
2019-01-07	Debiopharm International SA	Debiopharm Group regains the commercial rights to Trelstar® (Triptorelin pamoate) and looks for new partners in North America debiopharm.com ↗
2017-10-03	Debiopharm International SA	Arbor Pharmaceuticals, LLC and Debiopharm International SA Announce Commercial Availability of Triptodur™, Triptorelin 6-month Formulation, for Treatment of Central Precocious Puberty (CPP) debiopharm.com ↗
2017-06-30	Debiopharm International SA	Debiopharm International SA and Arbor Pharmaceuticals, LLC Announce U.S. FDA Approval for Triptodur™, Triptorelin 6-month Formulation, in the Treatment of Central Precocious Puberty (CPP) debiopharm.com ↗
2017-01-09	Debiopharm International SA	Debiopharm Group’s Triptorelin 6-month Formulation Receives Approval for the Treatment of Central Precocious Puberty (CPP) in Europe debiopharm.com ↗
2016-01-13	Debiopharm International SA	Debiopharm International SA and EORTC announce a collaboration to investigate Triptorelin for treatment of Salivary Gland Cancers debiopharm.com ↗
2016-01-11	Debiopharm International SA	Debiopharm International SA and Arbor Pharmaceuticals, LLC announce their US commercialization partnership for Triptorelin in Central Precocious Puberty debiopharm.com ↗
2015-05-19	Debiopharm International SA	Debiopharm International SA Announces Phase III Positive Results for Triptorelin 6-month Formulation in the Management of Central Precocious Puberty (CPP) debiopharm.com ↗
2014-01-13	Debiopharm International SA	Debiopharm Group™ Announces Completion of Recruitment for Phase III Clinical Study with Triptorelin 22.5 mg in Central Precocious Puberty debiopharm.com ↗
2009-10-13	Debiopharm International SA	Ipsen and Debiopharm Group announce that Decapeptyl® (triptorelin embonate) 6-month successfully completes the European Decentralised Procedure for the treatment of locally advanced or metastatic prostate cancer debiopharm.com ↗
2009-07-21	Debiopharm International SA	Swissmedic grants Debiopharm marketing authorisation for Moapar® – A new therapeutic avenue for the treatment of sexual deviations debiopharm.com ↗
2009-03-31	Debiopharm International SA	Bachem and Debiopharm sign follow-up contract for long-term supply of Triptorelin Pamoate debiopharm.com ↗
2006-06-20	Debiopharm International SA	Moapar® 3-months approved for the lowering of testosterone to castrate serum levels for control of sexual drive in adult men debiopharm.com ↗
2003-12-02	Debiopharm International SA	Debiopharm S.A. seeks New Partner to Commercialise Trelstar® (Triptorelin Pamoate) in the US, Canada and Mexico for the Treatment of Prostate Cancer debiopharm.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

Field	Value	Cited text
Known as	Debio 4326	ClinicalTrials.gov intervention name — accepted as the source's own label NCT06129539 ↗
Known as	Triptorelin	“LIBELULA™: An Open-label, Single-arm, Multi-center, Phase 3 Study on the Efficacy, Safety, and Pharmacokinetics of Debio 4326, a Triptorelin 12-month Formulation, in Pediatric...” NCT06129539 ↗
Action	Inhibit	“evaluate the efficacy of Debio 4326 in suppressing serum luteinizing hormone (LH) to prepubertal levels” NCT06129539 ↗
Route	Intramuscular	“Administered as an intramuscular (IM) injection” NCT06129539 ↗