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histrelin

Generic: HISTRELIN ACETATE·Brand: SUPPRELIN, SUPPRELIN LA, Supprelin, VANTAS

histrelin: developed by 1 company · 3 clinical trials tracked · 1 FDA decision.

histrelin evidence translation

What we can confirm

1 FDA record · 3 tracked trials

What it means

Source-backed records connect histrelin to NDOI; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could histrelin → NDOI affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence0 indications · 2 study sponsors

Related indications

No linked indication is available.

Development Pipeline (2)
CompanyPhase
Endo LP (NDOI)Approved
Endo LP (NDOI)Approved
Clinical Trials (3)

MC230502 Dynamic Investigator Initiated Enterprise (DIVINE) in Prostate Cancer

NCT06378866·Phase 2·KYNB
Recruiting

Primary endpoint: Modified radiographic progression-free survival (mrPFS) (Groups A & B)

InterventionalRandomizedopen532 targetStarted 2024-06Completion 2029-053 sites · United StatesMayo Clinic

Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)

NCT05050084·Phase 3·CGON
Active, not recruiting

Primary endpoint: Distant metastasis (DM) (De-intensification study)

InterventionalRandomizedopen2,050 targetStarted 2021-12Completion 2026-1150 sites · United StatesNRG Oncology

Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)

NCT04513717·Phase 3·CGON
Active, not recruiting

Primary endpoint: Metastasis-free survival (MFS)

InterventionalRandomizedopen2,753 enrolledStarted 2021-01Completion 2038-1250 sites · United StatesNRG Oncology
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment. Prior to initiation of treatment a clinical diagnosis of CPP shou(NDOI)FDA ↗
NDA022058Type 5 - New Formulation or New ManufacturerOrphan DrugStandardSubcutaneousImplant

Frequently asked questions

Who is developing histrelin?

histrelin is being developed by Endo LP.

How many clinical trials involve histrelin?

BioSniper tracks 3 clinical trials involving histrelin.

What is histrelin's latest FDA decision?

The most recent tracked FDA decision for histrelin is Approval for 1 INDICATIONS AND USAGE SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment. Prior to initiation of treatment a clinical diagnosis of CPP shou, dated May 3, 2007.