Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SIR2501 · 1 trial · 1 indication
Incidence of Treatment-Emergent Adverse Events
| Arm | Type | Description |
|---|---|---|
| 30 mg | EXPERIMENTAL | - |
| 45 mg | EXPERIMENTAL | - |
| 60 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SIR2501 | DRUG | Experimental: 30 mg SIR2501 administered at 30 mg dose level. Experimental: 45 mg SIR2501 administered at 45 mg dose level. Experimental: 60 mg SIR2501 administered at 60 mg dose level. |
Inclusion Criteria: * Adults ≥18 years with confirmed solid tumors * Planned treatment with paclitaxel-based chemotherapy * ECOG performance status 0-2 Exclusion Criteria: * Pre-existing peripheral neuropathy * Conditions or medications that may interfere with neuropathy assessment * Prior exposu...
SIR2501 is an investigational small molecule being studied for the treatment of chemotherapy-induced peripheral neuropathy, a nerve damage condition caused by cancer treatments like paclitaxel. It is currently in Phase 2 clinical development and has not been approved by the FDA.
SIR2501 is being developed by BrainsWay Ltd., a company traded on the stock exchange under the ticker BWAY. The company is conducting a Phase 2 clinical trial to evaluate the drug's safety and efficacy in patients with chemotherapy-induced peripheral neuropathy.
SIR2501 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is designed to assess its effects in patients with chemotherapy-induced peripheral neuropathy.
SIR2501 is being evaluated in a Phase 2 clinical trial with the identifier NCT07765446, titled 'Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel.' The trial is not yet recruiting and plans to enroll 18 participants in the United States.
No, SIR2501 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for chemotherapy-induced peripheral neuropathy. The drug has not completed clinical development, and its safety and efficacy have not been established for regulatory approval.