Drug Profile

Pexidartinib - Daiichi Sankyo

Alternative Names: Pexidartinib hydrochloride; Plexxikon 3397; PLX-3397; TURALIO

Latest Information Update: 02 Feb 2026

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At a glance

Originator Plexxikon
Developer Array BioPharma; AstraZeneca; Barbara Ann Karmanos Cancer Institute; Columbia University; Daiichi Sankyo Company; Memorial Sloan-Kettering Cancer Center; Merck & Co; National Cancer Institute (USA); Plexxikon; The Christie NHS Foundation Trust; University of California at San Francisco
Class 2 ring heterocyclic compounds; Antidementias; Antineoplastics; Fluorine compounds; Pyridines; Pyrroles; Small molecules
Mechanism of Action Fms-like tyrosine kinase 3 inhibitors; Macrophage colony-stimulating factor receptor antagonists; Proto-oncogene protein c-kit inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Giant cell tumour of tendon sheath; Pigmented villonodular synovitis
New Molecular Entity Yes

Marketed Giant cell tumour of tendon sheath
Phase II Acral lentiginous melanoma; Glioblastoma; Malignant melanoma; Prostate cancer
Phase I/II Acute myeloid leukaemia; Breast cancer; Gastrointestinal stromal tumours; Leukaemia; Sarcoma; Solid tumours
No development reported Colorectal cancer; Pancreatic cancer
Discontinued Alzheimer's disease; Hodgkin's disease; Neurological disorders; Rheumatoid arthritis

02 Feb 2026 Pexidartinib is still in phase III trial for Giant cell tumour of tendon sheath in Japan (PO)
02 Feb 2026 Pexidartinib is still in phase III trial for Giant cell tumour of tendon sheath in Taiwan, China (PO) (NCT04488822)
09 Jul 2025 Final long term efficacy and safety data from the phase III ENLIVEN trial in Giant cell tumour of the tendon sheath released by Daiichi Sankyo

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