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Pimicotinib · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Safety Run-In followed by Expansion Cohort: Pimicotinib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Pimicotinib | DRUG | In the Safety Run-in Cohort, participants will receive 50 milligrams (mg) of pimicotinib once daily (QD), orally in 28-day cycles until disease progression (DP), death, discontinuation, or any other reason. The Safety Monitoring Committee (SMC) will monitor and assess tolerability of pimicotinib 50 mg QD during the safety run-in cohort. After making a recommendation about opening the Expansion Cohort based on the assessment in safety run-in cohort, participants will receive 50 mg of pimicotinib monotherapy QD, orally in 28-day cycles until disease progression (DP), death, discontinuation, or any other reason. |
Inclusion Criteria: * Japanese participants with a diagnosis of TGCT that has been histologically confirmed at the local laboratory and is unresectable (that is \[i.e.\] it is located in a complex anatomical site, extensively invasive, and cannot be completely resected; or a surgical operation may ...
Pimicotinib is an investigational small molecule being studied for the treatment of Tenosynovial Giant Cell Tumor (TGCT), a type of tumor that affects the joints. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Pimicotinib is a kinase inhibitor, as indicated by its '-tinib' suffix. It is being studied for its potential to target kinases involved in the growth of Tenosynovial Giant Cell Tumor. The specific molecular target has not been disclosed in available information.
Pimicotinib is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Tenosynovial Giant Cell Tumor.
Pimicotinib is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received approval from regulatory agencies such as the FDA. The ongoing Phase 2 trial is recruiting participants to further assess its effects.
Pimicotinib is being evaluated in a Phase 2 clinical trial with the identifier NCT07499362, titled 'Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)'. This single-arm, open-label study is recruiting 20 participants in Japan and is not yet completed.
No alternative names for Pimicotinib have been reported. It is identified solely by its generic name in clinical trial registries and scientific literature. Patients and healthcare providers should refer to it as Pimicotinib when discussing this investigational therapy.