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HISTRELIN ACETATE
HISTRELIN ACETATE is a drug. It is currently FDA-approved (first approved 1991) for Central Precocious Puberty (CPP).
Histrelin Acetate is a marketed drug primarily indicated for the treatment of Central Precocious Puberty (CPP), positioning it in a niche but critical therapeutic area. Its key strength lies in its established market presence, supported by a key composition patent that remains in effect until 2028. The primary risk is the eventual patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | HISTRELIN ACETATE |
|---|---|
| Modality | Recombinant protein |
| Phase | FDA-approved |
| First approval | 1991 |
Approved indications
- Central Precocious Puberty (CPP)
Common side effects
- Implant site reaction
- Implant site bruising
- Implant site pain
- Implant site soreness
- Implant site erythema
- Implant site swelling
- Implant site discomfort
- Implant site tingling
- Implant site itching
- Implant area protrusion
- Metrorrhagia
Serious adverse events
- Pituitary adenoma (benign pituitary tumor)
- Amblyopia
- Implant site infection
- Depression with suicidal ideation and attempt
- Seizures
- Pseudotumor cerebri (idiopathic intracranial hypertension)
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Implant breakage
- Emotional lability with aggression
Key clinical trials
- Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial (PHASE3)
- Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial (PHASE3)
- Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial (PHASE2)
- Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (PHASE2, PHASE3)
- Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer (PHASE3)
- Skeletal Health and Bone Marrow Composition Among Youth (NA)
- Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer (PHASE2)
- A Study Called AWARENESS Using Data From Men in Alberta to Observe Treatment Patterns for Metastatic Castration-sensitive Prostate Cancer
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- HISTRELIN ACETATE CI brief — competitive landscape report
- HISTRELIN ACETATE updates RSS · CI watch RSS
Frequently asked questions about HISTRELIN ACETATE
What is HISTRELIN ACETATE?
What is HISTRELIN ACETATE used for?
When was HISTRELIN ACETATE approved?
What development phase is HISTRELIN ACETATE in?
What are the side effects of HISTRELIN ACETATE?
Related
- Indication: Drugs for Central Precocious Puberty (CPP)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing