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Gosipol (GOSSYPOL)
Gosipol (generic name: GOSSYPOL) is a gossypol drug. It is currently in Phase 3 development.
Gossypol works by binding to and inhibiting the Bcl-2 protein, which is involved in regulating cell death.
Gossypol, also known as GOSSYPOL, is a small molecule drug that targets the apoptosis regulator Bcl-2. It is a member of the gossypol drug class and was originally developed by. However, its current owner is unknown. Gossypol has not been approved by the FDA for any indications, and its commercial status, including whether it is patented or generic, is also unknown.
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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 | GOSSYPOL |
|---|---|
| Drug class | gossypol |
| Target | Aspartyl/asparaginyl beta-hydroxylase, Apoptosis regulator Bcl-W, Bcl-2-like protein 1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Think of Bcl-2 as a guardian that helps keep cells alive. Gossypol is like a key that locks the guardian in place, preventing it from doing its job and allowing the cell to die. This can be helpful in treating certain types of cancer.
Approved indications
Common side effects
Key clinical trials
- Gossypol Acetate + FOLFIRI + Bev in mCRC With TP53-Mutant and LRPPRC Positive (PHASE2)
- High-frequency tRNS for Sleep Disturbances in Neurocognitive Disorders Due to Vascular Disease (NA)
- Gossypol Acetic Acid With Lenalidomide and Dexamethasone in Treating Patients With Relapsed Symptomatic Multiple Myeloma (PHASE1)
- Dalpiciclib Combination With Fulvestrant and Compound Gossyfol Acetate Tablets in Women With CDK4/6 Inhibitor-refractory HR-positive HER-2 Negtive Metastatic Breast Cancer: a Phase 2 Clinical Trial. (PHASE2)
- Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In Adults With Advanced Laryngeal Cancer (PHASE2)
- Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (PHASE1,PHASE2)
- Lenalidomide and AT-101 in Treating Patients With Relapsed B-Cell Chronic Lymphocytic Leukemia (PHASE1,PHASE2)
- Gossypol in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme (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:
- Gosipol CI brief — competitive landscape report
- Gosipol updates RSS · CI watch RSS
Frequently asked questions about Gosipol
What is Gosipol?
How does Gosipol work?
What is the generic name of Gosipol?
What drug class is Gosipol in?
What development phase is Gosipol in?
What does Gosipol target?
Related
- Drug class: All gossypol drugs
- Target: All drugs targeting Aspartyl/asparaginyl beta-hydroxylase, Apoptosis regulator Bcl-W, Bcl-2-like protein 1
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing