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Androgen Suppression Therapy
Androgen Suppression Therapy is a Androgen deprivation therapy (ADT) Small molecule drug developed by Proton Collaborative Group. It is currently in Phase 3 development for Metastatic hormone-sensitive prostate cancer, Locally advanced prostate cancer (in combination with radiation therapy). Also known as: leuprolide, goserelin, buserelin, or triptorelin.
Androgen suppression therapy reduces circulating testosterone and DHT levels to inhibit androgen-dependent cancer cell growth.
Androgen suppression therapy reduces circulating testosterone and DHT levels to inhibit androgen-dependent cancer cell growth. Used for Metastatic hormone-sensitive prostate cancer, Locally advanced prostate cancer (in combination with radiation therapy).
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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 | Androgen Suppression Therapy |
|---|---|
| Also known as | leuprolide, goserelin, buserelin, or triptorelin |
| Sponsor | Proton Collaborative Group |
| Drug class | Androgen deprivation therapy (ADT) |
| Target | Androgen receptor pathway / testosterone / DHT |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This therapeutic approach works by lowering systemic androgens through various mechanisms (GnRH agonists, antagonists, or 5-alpha reductase inhibitors), thereby depriving androgen-sensitive tumors of growth signals. It is commonly used in prostate cancer management to slow or halt progression of hormone-responsive disease.
Approved indications
- Metastatic hormone-sensitive prostate cancer
- Locally advanced prostate cancer (in combination with radiation therapy)
Common side effects
- Hot flashes
- Erectile dysfunction
- Decreased libido
- Gynecomastia
- Bone loss / osteoporosis
- Fatigue
- Weight gain
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)
- Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment (PHASE3)
- High-Risk prostatE Cancer radiatiOn Versus surgERy
- An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. (PHASE3)
- PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer (PHASE2, PHASE3)
- SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy (NA)
- Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in 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 |
|---|---|
| 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:
- Androgen Suppression Therapy CI brief — competitive landscape report
- Androgen Suppression Therapy updates RSS · CI watch RSS
- Proton Collaborative Group portfolio CI
Frequently asked questions about Androgen Suppression Therapy
What is Androgen Suppression Therapy?
How does Androgen Suppression Therapy work?
What is Androgen Suppression Therapy used for?
Who makes Androgen Suppression Therapy?
Is Androgen Suppression Therapy also known as anything else?
What drug class is Androgen Suppression Therapy in?
What development phase is Androgen Suppression Therapy in?
What are the side effects of Androgen Suppression Therapy?
What does Androgen Suppression Therapy target?
Related
- Drug class: All Androgen deprivation therapy (ADT) drugs
- Target: All drugs targeting Androgen receptor pathway / testosterone / DHT
- Manufacturer: Proton Collaborative Group — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic hormone-sensitive prostate cancer
- Indication: Drugs for Locally advanced prostate cancer (in combination with radiation therapy)
- Also known as: leuprolide, goserelin, buserelin, or triptorelin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing