histrelin
histrelin: sourced relationships with 1 company · 4 clinical trials tracked · 1 FDA decision.
histrelin evidence translation
What we can confirm
1 FDA record · 4 tracked trials
What it means
What to watch
Prepared research question
How could histrelin → NDOI affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
Dated Pipeline Records (2)
| Company | Dated record stage |
|---|---|
| Endo LP (NDOI) Reported 2007-05-03 · Current development: unknownSource | Approved |
| Endo LP (NDOI) Reported 2007-05-03 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (4)
MC230502 Dynamic Investigator Initiated Enterprise (DIVINE) in Prostate Cancer
Primary endpoint: Modified radiographic progression-free survival (mrPFS) (Groups A & B)
Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)
Primary endpoint: Distant metastasis (DM) (De-intensification study)
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*)
Primary endpoint: Metastasis-free survival (MFS)
Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer
Primary endpoint: Overall survival (OS)
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with histrelin?
histrelin has dated SEC/FDA relationship records for Endo LP.
How many clinical trials involve histrelin?
BioSniper tracks 4 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.