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RO4917838
RO4917838 is a small molecule that targets the CDK9 protein.
RO4917838 is a small molecule that targets the CDK9 protein. Used for Metastatic non-small cell lung cancer, Metastatic breast cancer.
At a glance
| Generic name | RO4917838 |
|---|---|
| Sponsor | Hoffmann-La Roche |
| Drug class | CDK9 inhibitor |
| Target | CDK9 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
CDK9 is a crucial component of the positive transcription elongation factor b (P-TEFb) complex, which is involved in the regulation of RNA polymerase II-mediated transcription. By inhibiting CDK9, RO4917838 aims to reduce the expression of genes involved in cancer cell proliferation and survival.
Approved indications
- Metastatic non-small cell lung cancer
- Metastatic breast cancer
Common side effects
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- Study of Bitopertin in Participants With EPP or XLP (APOLLO) (PHASE3)
- Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPP (PHASE2)
- HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLP (PHASE2, PHASE3)
- A Study of Bitopertin (RO4917838) in Adults With Non-Transfusion-Dependent (NTD) Beta-Thalassemia (PHASE2)
- A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD) (PHASE2)
- A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310) (PHASE3)
- A Pharmacodynamic and Pharmacokinetic Study of RO4917838 in Healthy Volunteers (PHASE1)
- A Study to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (PHASE3)
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:
- RO4917838 CI brief — competitive landscape report
- RO4917838 updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI