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LHRH Analogue
LHRH Analogue is a LHRH agonist Small molecule drug developed by Alliance Foundation Trials, LLC.. It is currently in Phase 3 development for Hormone-sensitive prostate cancer, Hormone-responsive breast cancer, Endometriosis. Also known as: Degarelix (Firmagon), Leuprolide (Lupron) and Bicalutamide, Goserelin, Leuprolide.
LHRH analogues suppress gonadotropin-releasing hormone signaling to reduce sex hormone production.
LHRH Analogue is a small molecule modality used to treat conditions such as biochemically-relapsing Prostate Adenocarcinoma Following Radical Prostatectomy, Prostate Cancer, and mCRPC, as indicated by ClinicalTrials.gov.
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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 | LHRH Analogue |
|---|---|
| Also known as | Degarelix (Firmagon), Leuprolide (Lupron) and Bicalutamide, Goserelin, Leuprolide |
| Sponsor | Alliance Foundation Trials, LLC. |
| Drug class | LHRH agonist |
| Target | LHRH receptor (GnRH receptor) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
LHRH (Luteinizing Hormone-Releasing Hormone) analogues bind to and activate LHRH receptors on pituitary gonadotroph cells. With continuous exposure, they cause desensitization and downregulation of the receptor, leading to sustained suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), which ultimately reduces testosterone and estrogen production.
Approved indications
- Hormone-sensitive prostate cancer
- Hormone-responsive breast cancer
- Endometriosis
- Uterine fibroids
Common side effects
- Hot flashes
- Decreased libido
- Erectile dysfunction
- Injection site reactions
- Fatigue
- Gynecomastia
Key clinical trials
- A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss (PHASE2)
- A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer (PHASE1, PHASE2)
- Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma (PHASE2)
- A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma (PHASE2)
- Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET/CT Evaluation in mHSCP Patients (PHASE2)
- Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
- Body Composition Assessment in Transgender Population.
- Artificial Cycle With or Without GnRH Agonist Pre-treatment for Frozen Embryo Transfer in Adenomyosis Patients (NA)
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:
- LHRH Analogue CI brief — competitive landscape report
- LHRH Analogue updates RSS · CI watch RSS
- Alliance Foundation Trials, LLC. portfolio CI
Frequently asked questions about LHRH Analogue
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Related
- Drug class: All LHRH agonist drugs
- Target: All drugs targeting LHRH receptor (GnRH receptor)
- Manufacturer: Alliance Foundation Trials, LLC. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Hormone-sensitive prostate cancer
- Indication: Drugs for Hormone-responsive breast cancer
- Indication: Drugs for Endometriosis
- Also known as: Degarelix (Firmagon), Leuprolide (Lupron) and Bicalutamide, Goserelin, Leuprolide
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing