Pimicotinib
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| Clinical data | |
|---|---|
| Synonyms | ABSK021 |
| Routes of administration | Oral |
| Legal status | |
| Legal status |
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| Identifiers | |
| CAS Number | |
| E number | {{#property:P628}} |
| ECHA InfoCard | {{#property:P2566}} |
| Chemical and physical data | |
| Formula | C22H24N6O3 . HCl . H2O |
| Molar mass | 474.95 g.mol-1 |
| 3D model (JSmol) | |
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Pimicotinib (ABSK021), an oral, highly potent and selective small molecule inhibitor of colony-stimulating factor 1 receptor (CSF-1R) independently discovered by Abbisko Therapeutics. A number of studies have shown that blocking the CSF-1R signaling pathway could effectively modulate and change macrophage functions, and potentially treat many macrophage-dependent human diseases.[1]
Medical uses[edit]
Pimicotinib is currently being investigated as a treatment for TGCT [2], chronic graft-versus-host-disease (cGVHD), and pancreatic cancer.
History[edit]
December 2023, Abbisko Therapeutics has entered into a licensing agreement for pimicotinib in all indications for China rights with Merck KGaA.[3] [4] [5]
In April 2023, pimicotinib has entered into a global Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the safety and efficacy of pimicotinib in patients with TGCT (NCT05804045).[6]
Following with pimicotinib for TGCT treatment in phase III, pimicotinib has also entered into a phase II trial in June 2023 for cGVHD treatment in China.[7]
The U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of NMPA granted pimicotinib breakthrough therapy designation (BTD) for the treatment of TGCT patients that are not amenable to surgery in January 2023 and July 2022, respectively.[8]
Soceity and culture[edit]
Pimicotinib is the first small-molecule inhibitor in Abbisko Therapeutics's pipeline that has been approved for Phase III clinical trial in both China and U.S., and it is the first CSF-1R inhibitor developed in China entering a global Phase III clinical trial.
References[edit]
- ↑ Vaynrub A, Healey JH, Tap W, Vaynrub M (2022). "Pexidartinib in the Management of Advanced Tenosynovial Giant Cell Tumor: Focus on Patient Selection and Special Considerations". OncoTargets and Therapy. 15: 53–66. doi:10.2147/OTT.S345878. PMC 8763255 Check
|pmc=value (help). PMID 35046667 Check|pmid=value (help). - ↑ PIMICOTINIB CLINICAL TRIAL. TGCT Support.https://www.tgctsupport.org/pimicotinib.html
- ↑ Merck Strengthens Oncology Portfolio Through Commercialization Agreement With Abbisko for Phase III Asset, Pimicotinib. (2023) https://www.merckgroup.com/en/news/abbisko-pimicotinib-agreement-04-12-2023.html
- ↑ Merck KGaA buys into Abbisko’s late-stage joint tumor med for $70M upfront. Fierce Biotech. (2023) https://www.fiercebiotech.com/biotech/merck-kgaa-buys-abbiskos-late-stage-joint-tumor-med-70m-upfront
- ↑ Abbisko Therapeutics Announced the Entry into a Licensing Agreement for Pimicotinib (ABSK021) with Merck. PRNewswire.(2023) https://www.prnewswire.com/news-releases/abbisko-therapeutics-announced-the-entry-into-a-licensing-agreement-for-pimicotinib-absk021-with-merck-302004423.html
- ↑ Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER). U. S. National Institutes of Health, National Cancer Institute. https://classic.clinicaltrials.gov/ct2/show/NCT05804045
- ↑ A Phase II Study Evaluating the Efficacy and Safety of ABSK021 (Pimicotinib)) in the Treatment of cGvHD Chronic Graft Versus Host Disease (cGvHD)U. S. National Institutes of Health, National Cancer Institute.https://classic.clinicaltrials.gov/ct2/show/NCT06186804
- ↑ FDA grants breakthrough therapy designation to Abbisko’s pimicotinib. Global Genes. (2023). https://globalgenes.org/raredaily/the-u-s-food-and-drug-administration-granted-abbisko-therapeutics-breakthrough-therapy-designation-for-pimicotinib-its-experimental-therapy-for-the-treatment-of-the-rare-cancer-tenosynovial-giant-ce/
External links[edit]
- "Pimicotinib". NCI Drug Dictionary. National Cancer Institute.
- Clinical trial number NCT05804045 for "Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)" at ClinicalTrials.gov
- Clinical trial number NCT06186804 for "A Phase II Study Evaluating the Efficacy and Safety of ABSK021 (Pimicotinib)) in the Treatment of cGvHD Chronic Graft Versus Host Disease (cGvHD)" at ClinicalTrials.gov
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