Pimicotinib
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This article, Pimicotinib, has recently been created via the Articles for creation process. Please check to see if the reviewer has accidentally left this template after accepting the draft and take appropriate action as necessary.
Reviewer tools: Inform author |
This article, Pimicotinib, has recently been created via the Articles for creation process. Please check to see if the reviewer has accidentally left this template after accepting the draft and take appropriate action as necessary.
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- Comment: Notable per references(did a few edits myself), thank you Ozzie10aaaa (talk) 17:36, 18 April 2024 (UTC)
- Comment: It looks better than the last review, but I think there are still some issues with WP:NPOV, the lack of secondary sources and, most importantly, the lack of context overall... Oltrepier (talk) 21:25, 4 November 2023 (UTC)
- Comment: Most refs are press-release or other publications by the company developing this chemical. WP:MEDRS is the relevant standard. The article itself sounds more like a press release than summarizing main ideas for encyclopedia readers, which is not an uncommon problem for writing by editors with COI (disclosed on their userpage but not here at article). All content will need to be checked for copyvio. DMacks (talk) 09:07, 23 August 2023 (UTC)
Clinical data | |
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Other names | ABSK021 |
Routes of administration | Oral |
Legal status | |
Legal status |
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Identifiers | |
CAS Number | |
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
Pimicotinib is currently being investigated as a treatment for TGCT [2][3], chronic graft-versus-host-disease (cGVHD), and pancreatic cancer.
History
December 2023, Abbisko Therapeutics has entered into a licensing agreement for pimicotinib in all indications for China rights with Merck KGaA.[4] [5][6]
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).[7]
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.[8]
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.[9]
References
- ^ 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. PMID 35046667.
- ^ "Pimicotinib". TGCT Support. Retrieved 18 April 2024.
- ^ "A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of ABSK021 to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor". clinicaltrials. clinicaltrials.gov. 10 April 2024. Retrieved 18 April 2024.
- ^ 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". www.prnewswire.com (Press release). Retrieved 18 April 2024.
- ^ 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. Retrieved 18 April 2024.
External links
- "Pimicotinib". NCI Drug Dictionary. National Cancer Institute.
- 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