Product Description
Pexidartinib is approved in the U.S. for tenosynovial giant cell tumors (TGCTs). (Sourced from: https://pubmed.ncbi.nlm.nih.gov/33289960/)
Mechanisms of Action: CSF-1R Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: European Medicines Agency | Korea | Taiwan | United States
Approved Indications: Oncology Unspecified
Known Adverse Events: Dysgeusia | Edema
Company: Daiichi Sankyo
Company Location: TOKYO M0 103-8426
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China, Japan, Taiwan
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: Giant Cell Tumor of Tendon Sheath|Giant Cell Tumors
Phase 2: Oncology Unspecified
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2041200074 | P2 |
Recruiting |
Oncology Unspecified |
2026-11-30 |
|
| PL3397-A-J304 | P2 |
Active, not recruiting |
Giant Cell Tumors|Giant Cell Tumor of Tendon Sheath |
2023-03-20 |
|
| PLX3397 | P3 |
Active, not recruiting |
Giant Cell Tumors|Giant Cell Tumor of Tendon Sheath |
2021-10-27 |
|
| CTR20201220 | P3 |
Recruiting |
Giant Cell Tumor of Tendon Sheath|Giant Cell Tumors |
None |