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Vantas (HISTRELIN)
Vantas works by binding to the gonadotropin-releasing hormone receptor, mimicking the natural hormone and reducing the production of sex hormones.
Vantas (Histrelin) is a small molecule gonadotropin-releasing hormone receptor agonist developed by an original developer, now owned by Endo Operations. It targets the gonadotropin-releasing hormone receptor to treat advanced prostatic carcinoma and precocious puberty. FDA approved in 1991, Vantas is off-patent with no active Orange Book patents, meaning it can be manufactured by generic manufacturers. However, currently, there are no generic manufacturers. It is essential to consider the potential side effects and interactions when prescribing Vantas.
At a glance
| Generic name | HISTRELIN |
|---|---|
| Sponsor | Endo Operations |
| Drug class | Gonadotropin Releasing Hormone Receptor Agonist |
| Target | Gonadotropin-releasing hormone receptor |
| Modality | Recombinant protein |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1991 |
Mechanism of action
SUPPRELIN LA is GnRH agonist and an inhibitor of gonadotropin secretion when given continuously. It delivers approximately 65 mcg histrelin acetate per day. Both animal and human studies indicate that following an initial stimulatory phase, chronic, subcutaneous administration of histrelin acetate desensitizes responsiveness of the pituitary gonadotropin which, in turn causes reduction in ovarian and testicular steroidogenesis.In humans, administration of histrelin acetate results in an initial increase in circulating levels of LH and FSH, leading to transient increase in concentration of gonadal steroids (testosterone and dihydrotestosterone in males, and estrone and estradiol in premenopausal females). However, continuous administration of histrelin acetate causes reversible down-regulation of the GnRH receptors in the pituitary gland and desensitization of the pituitary gonadotropes. These inhibitory effects result in decreased levels of LH and FSH.
Approved indications
- Advanced Prostatic Carcinoma
- Precocious puberty
Common side effects
- Hot flashes
- Fatigue
- Weight increased
- Implant site reaction
- Erectile dysfunction
- Gynecomastia
- Testicular atrophy
- Renal impairment
- Constipation
- Headache
- Libido decreased
- Bruising
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:
- Vantas CI brief — competitive landscape report
- Vantas updates RSS · CI watch RSS