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Leuprolide acetate - Formulation B
Leuprolide acetate - Formulation B is a GnRH agonist Small molecule drug developed by Abbott. It is currently in Phase 3 development for Advanced prostate cancer, Endometriosis, Uterine fibroids. Also known as: Lupron, leuprorelin, gonadotropin hormone-releasing hormone (GnRH), luteinizing hormone-releasing hormone (LHRH).
Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased sex hormone production.
Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased sex hormone production. Used for Advanced prostate cancer, Endometriosis, Uterine fibroids.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Leuprolide acetate - Formulation B |
|---|---|
| Also known as | Lupron, leuprorelin, gonadotropin hormone-releasing hormone (GnRH), luteinizing hormone-releasing hormone (LHRH) |
| Sponsor | Abbott |
| Drug class | GnRH agonist |
| Target | GnRH receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology; Endocrinology |
| Phase | Phase 3 |
Mechanism of action
Leuprolide works by binding to GnRH receptors in the pituitary gland, initially causing a surge in LH and FSH (flare effect), followed by sustained suppression of these hormones through receptor desensitization. This results in profound reduction of testosterone in males and estrogen in females, making it useful for hormone-dependent conditions. The sustained-release formulation (Formulation B) provides prolonged therapeutic effect over weeks to months.
Approved indications
- Advanced prostate cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
- Breast cancer (hormone-receptor positive)
Common side effects
- Hot flashes
- Injection site reaction
- Decreased libido
- Erectile dysfunction
- Headache
- Fatigue
- Gynecomastia
- Bone pain (flare reaction)
Key clinical trials
- A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty (PHASE3)
- A Study of Leuprolide to Treat Prostate Cancer (PHASE3)
- Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone (PHASE2)
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 |
|---|---|
| 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:
- Leuprolide acetate - Formulation B CI brief — competitive landscape report
- Leuprolide acetate - Formulation B updates RSS · CI watch RSS
- Abbott portfolio CI
Frequently asked questions about Leuprolide acetate - Formulation B
What is Leuprolide acetate - Formulation B?
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What is Leuprolide acetate - Formulation B used for?
Who makes Leuprolide acetate - Formulation B?
Is Leuprolide acetate - Formulation B also known as anything else?
What drug class is Leuprolide acetate - Formulation B in?
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What does Leuprolide acetate - Formulation B target?
Related
- Drug class: All GnRH agonist drugs
- Target: All drugs targeting GnRH receptor
- Manufacturer: Abbott — full pipeline
- Therapeutic area: All drugs in Oncology; Endocrinology
- Indication: Drugs for Advanced prostate cancer
- Indication: Drugs for Endometriosis
- Indication: Drugs for Uterine fibroids
- Also known as: Lupron, leuprorelin, gonadotropin hormone-releasing hormone (GnRH), luteinizing hormone-releasing hormone (LHRH)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing