Overview
Histrelin is a gonadotropin-releasing hormone (GnRH) agonist that acts as a potent inhibitor of gonadotropin when administered as an implant delivering continuous therapeutic doses. This drug is a synthetic analog of naturally occurring GnRH with a higher potency. Histrelin implants are non-biodegradable, diffusion-controlled, hydrogel polymer reservoirs containing histrelin acetate that need to be replaced every 52 weeks. Initially, histrelin implants were developed to reduce testosterone to castration levels in patients with advanced prostate cancer. The Vantas product was approved by the FDA in October 2004 for the palliative treatment of this condition. Vantas was later discontinued by Endo Pharmaceuticals Inc. on September 21, 2021. GnRH agonists are the first line of treatment for children with central precocious puberty (CPP) due to their capacity to reduce LH levels and the concentration of sex steroids. As the product Supprelin LA, histrelin is indicated for the treatment of CPP in children (approved by the FDA in May 2007).
Background
Histrelin is a gonadotropin-releasing hormone (GnRH) agonist that acts as a potent inhibitor of gonadotropin when administered as an implant delivering continuous therapeutic doses. This drug is a synthetic analog of naturally occurring GnRH with a higher potency. Histrelin implants are non-biodegradable, diffusion-controlled, hydrogel polymer reservoirs containing histrelin acetate that need to be replaced every 52 weeks. Initially, histrelin implants were developed to reduce testosterone to castration levels in patients with advanced prostate cancer. The Vantas product was approved by the FDA in October 2004 for the palliative treatment of this condition. Vantas was later discontinued by Endo Pharmaceuticals Inc. on September 21, 2021. GnRH agonists are the first line of treatment for children with central precocious puberty (CPP) due to their capacity to reduce LH levels and the concentration of sex steroids. As the product Supprelin LA, histrelin is indicated for the treatment of CPP in children (approved by the FDA in May 2007).
Indication
As the product Supprelin LA (FDA), histrelin is indicated for the treatment of children with central precocious puberty (CPP). As the product Vantas (FDA), histrelin is indicated for the palliative treatment of advanced prostate cancer.
Associated Conditions
- Advanced Prostate Cancer
- Central Precocious Puberty (CPP)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/04/23 | Phase 2 | Recruiting | |||
2021/09/20 | Phase 3 | Recruiting | |||
2020/08/14 | Phase 3 | Recruiting | |||
2018/09/19 | Phase 3 | Recruiting | |||
2014/10/29 | Phase 2 | Completed | |||
2012/10/02 | Phase 3 | Completed | Endo Pharmaceuticals | ||
2011/07/14 | Phase 3 | Completed | Endo Pharmaceuticals | ||
2008/10/24 | Phase 3 | Completed | Endo Pharmaceuticals |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Endo Pharmaceuticals Inc. | 67979-002 | SUBCUTANEOUS | 50 mg in 1 1 | 4/28/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||