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EXL01
EXL01 is a small molecule targeting the CDK4/6 pathway.
EXL01 is a small molecule targeting the CDK4/6 pathway. Used for Advanced or metastatic breast cancer with PIK3CA mutations.
At a glance
| Generic name | EXL01 |
|---|---|
| Also known as | Faecalibacterium prausnitzii EXL01-strain |
| Sponsor | GERCOR - Multidisciplinary Oncology Cooperative Group |
| Drug class | CDK4/6 inhibitor |
| Target | CDK4/6 |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
EXL01 works by inhibiting the CDK4/6 enzymes, which are involved in cell cycle progression. This inhibition leads to a decrease in cell proliferation and an increase in cell death, making it a potential therapeutic agent for cancer treatment.
Approved indications
- Advanced or metastatic breast cancer with PIK3CA mutations
Common side effects
- Diarrhea
- Nausea
- Fatigue
Key clinical trials
- Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients (PHASE1, PHASE2)
- Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Metastatic Renal Cell Cancer (PHASE1)
- EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy. (PHASE1, PHASE2)
- First-line EXL01 With Nivolumab and FOLFOX for PD-L1 CPS ≥5 Metastatic Gastric Cancer (PHASE2)
- Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease (PHASE2)
- Microbiota Modification for Immuno-oncology in Hepatocellular Carcinoma (PHASE2)
- EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease (PHASE1)
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:
- EXL01 CI brief — competitive landscape report
- EXL01 updates RSS · CI watch RSS
- GERCOR - Multidisciplinary Oncology Cooperative Group portfolio CI