Drugs / Pimicotinib
Pimicotinib
also known as
ABSK021 · ABSK-021 FREE BASE ANHYDROUS · ABSK-021-0 · ABSK-021-0 FREE BASE ANHYDROUS · ABSK-021-7 · ABSK021-NX · ASYM-132018 · ASYM-133040 · +1 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | tenosynovial giant cell tumor | 2026-01-12 | “pimicotinib (ABSK021), for the systemic treatment of patients with tenosynovial giant cell tumor (TGCT), has been formally accepted by the U.S. Food and Drug Administration (FDA)” abbisko.com ↗ “Merck KGaA, Darmstadt, Germany announced today that the U.S. FDA has accepted the company’s NDA for pimicotinib.” emdgroup.com ↗ |
| Filed | China (NMPA) | — | tenosynovial giant cell tumor | 2025-06-10 | “The Center for Drug Evaluation of the China National Medical Products Administration officially accepted the application for pimicotinib for TGCT.” emdgroup.com ↗ “NMPA has accepted the New Drug Application (NDA) for pimicotinib” abbisko.com ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT07210996 | Sep → Oct 2025 | — | Abbisko Therapeutics Co, Ltd | Completed | No outcome recorded |
| Phase 1 | NCT06884072 | Apr → Jul 2025 overdue | — | Abbisko Therapeutics Co, Ltd | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06779253 | Mar → Apr 2025 | — | Abbisko Therapeutics Co, Ltd | Completed | No outcome recorded |
| Phase 1 | NCT06694948 | Dec 2024 → Jan 2025 | — | Abbisko Therapeutics Co, Ltd | Completed | No outcome recorded |
| Phase 1 | NCT06562946 | Sep → Dec 2024 | — | Abbisko Therapeutics Co, Ltd | Completed | No outcome recorded |
| Phase 1 | NCT06322706 | Mar → Nov 2024 | — | Abbisko Therapeutics Co, Ltd | Completed | No outcome recorded |
| Phase 1 | NCT06186583 | Dec 2023 → May 2024 | — | Abbisko Therapeutics Co, Ltd | Completed | No outcome recorded |
| Phase 1 | NCT06089733 | Apr → Aug 2023 | — | Abbisko Therapeutics Co, Ltd | Completed | No outcome recorded |
| Phase 1 | NCT05280483 | Jul → Aug 2022 | neoplasm | Abbisko Therapeutics Co, Ltd | Completed | No outcome recorded |
| Phase 1 | NCT04192344 | Jan 2020 → Dec 2026 expected | tenosynovial giant cell tumor | Abbisko Therapeutics Co, Ltd | Recruiting | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07707882 | Oct 2027 → Sep 2029 expected | tenosynovial giant cell tumor, diffuse type | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07499362 | Mar 2026 → Nov 2029 expected | tenosynovial giant cell tumor | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Recruiting | No outcome recorded |
| Phase 2 | NCT06111274 | Oct 2023 → Dec 2025 overdue | pancreatic neoplasm | Abbisko Therapeutics Co, Ltd | Recruiting | No outcome recorded |
| Phase 2 | NCT06186804 | May 2023 → Oct 2026 expected | chronic graft versus host disease | Abbisko Therapeutics Co, Ltd | Enrolling by invitation | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05804045 | Apr 2023 → Sep 2024 overdue | tenosynovial giant cell tumor | Abbisko Therapeutics Co, Ltd | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 41
| Date | Issuer | Release |
|---|---|---|
| 2026-03-08 | Abbisko Therapeutics Co, Ltd | Results The Lancet Publishes Global Phase 3 MANEUVER Study Results of Pimicotinib abbisko.com ↗ |
| 2026-01-13 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Announces FDA Acceptance of the NDA for Pimicotinib for the Treatment of Tenosynovial Giant Cell Tumor abbisko.com ↗ |
| 2026-01-12 | EMD Serono Research & Development Institute, Inc. | Regulatory FDA Accepts New Drug Application for Pimicotinib for the Treatment of Tenosynovial Giant Cell Tumor emdserono.com ↗ |
| 2026-01-12 | Merck KGaA, Darmstadt, Germany | Regulatory FDA Accepts New Drug Application for Pimicotinib for the Treatment of Tenosynovial Giant Cell Tumor emdgroup.com ↗
Merck KGaA, Darmstadt, Germany announced today that the U.S. FDA has accepted the company’s NDA for pimicotinib. |
| 2025-12-22 | EMD Serono Research & Development Institute, Inc. | Regulatory Pimicotinib Approved as Systemic Treatment in China for Tenosynovial Giant Cell Tumor emdserono.com ↗ |
| 2025-12-22 | Merck KGaA, Darmstadt, Germany | Regulatory Pimicotinib Approved as Systemic Treatment in China for Tenosynovial Giant Cell Tumor emdgroup.com ↗
The China National Medical Products Administration (NMPA) has approved pimicotinib for adult patients with symptomatic tenosynovial giant cell tumor. |
| 2025-12-22 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics’ CSF-1R Inhibitor Pimicotinib Approved by the China NMPA, Addressing the Treatment Gap for Tenosynovial Giant Cell Tumor abbisko.com ↗ |
| 2025-11-17 | Abbisko Therapeutics Co, Ltd | Results Abbisko Therapeutics Presents Longer-Term Efficacy and Safety Outcomes from Phase III MANEUVER Study of Pimicotinib at CTOS 2025 Annual Meeting abbisko.com ↗
This longer-term analysis showed that sustained treatment with pimicotinib in patients with TGCT led to continued improvements in tumor response, patient-reported outcomes including pain and function, and maintained an acceptable safety profile, reinforcing its potential for long-term use in eligible patients. |
| 2025-10-20 | Abbisko Therapeutics Co, Ltd | Results ESMO 2025 | Abbisko Therapeutics Presents Longer-Term Efficacy and Safety Outcomes from Phase III MANEUVER Trial of Pimicotinib abbisko.com ↗
20 October 2025, Shanghai – Abbisko Therapeutics Co. Ltd. (Abbisko Therapeutics 00256.HK) announced that longer-term efficacy and safety outcomes from the global phase III MANEUVER trial of pimicotinib (ABSK021) in patients with tenosynovial giant cell tumour (TGCT) were presented at the ESMO Congress 2025. |
| 2025-10-17 | EMD Serono Research & Development Institute, Inc. | Results Pimicotinib Treatment Demonstrates Deep and Durable Tumor Responses and Continued Improvements in Pain and Function for Patients with TGCT emdserono.com ↗
The study also showed continued clinically meaningful improvements in key secondary endpoints related to patient outcomes such as pain and function. |
| 2025-10-17 | Merck KGaA, Darmstadt, Germany | Results Pimicotinib Treatment Demonstrates Deep and Durable Tumor Responses and Continued Improvements in Pain and Function for Patients With TGCT emdgroup.com ↗
The study also showed continued clinically meaningful improvements in key secondary endpoints related to patient outcomes such as pain and function. |
| 2025-06-10 | EMD Serono Research & Development Institute, Inc. | Regulatory China’s Center for Drug Evaluation Accepts Merck KGaA, Darmstadt, Germany’s Application for Marketing Authorization of Pimicotinib for Treatment of Tenosynovial Giant Cell Tumor emdserono.com ↗ |
| 2025-06-10 | Merck KGaA, Darmstadt, Germany | Regulatory China’s Center for Drug Evaluation Accepts Merck KGaA, Darmstadt, Germany’s Application for Marketing Authorization of Pimicotinib for Treatment of Tenosynovial Giant Cell Tumor emdgroup.com ↗
The Center for Drug Evaluation of the China National Medical Products Administration officially accepted the application for pimicotinib for TGCT. |
| 2025-06-10 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Announces China NMPA Acceptance of New Drug Application for Pimicotinib for the Treatment of TGCT abbisko.com ↗
Abbisko Therapeutics Co., Ltd. (02256.HK) today announced that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for pimicotinib, a highly selective, small-molecule CSF-1R inhibitor, as a Class 1 innovative drug for adult patients with Tenosynovial Giant Cell Tumor (TGCT). |
| 2025-05-28 | EMD Serono Research & Development Institute, Inc. | Results Pimicotinib Demonstrates Best-in-Class Potential with Significant Efficacy and Clinically Meaningful Improvements in Patients with Tenosynovial Giant Cell Tumor emdserono.com ↗
Global Phase 3 MANEUVER study of pimicotinib in tenosynovial giant cell tumor (TGCT) met the primary endpoint, demonstrating objective response rate at week 25 of 54.0% versus 3.2% for placebo (p<0.0001) |
| 2025-05-28 | Merck KGaA, Darmstadt, Germany | Results Pimicotinib Demonstrates Best-in-Class Potential with Significant Efficacy and Clinically Meaningful Improvements in Patients with Tenosynovial Giant Cell Tumor emdgroup.com ↗
Merck KGaA, Darmstadt, Germany, today announced the presentation of detailed positive results from Part 1 of the global Phase 3 MANEUVER trial evaluating pimicotinib in TGCT. |
| 2025-05-22 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Showcases Innovation in Advanced Cancers and Rare Tumors at ASCO 2025 emdserono.com ↗
Data from Phase 3 MANEUVER study demonstrating significant improvements in physical function and symptoms in patients with tenosynovial giant cell tumor (TGCT) treated with pimicotinib, to be featured in oral presentation |
| 2025-05-22 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany, Showcases Innovation in Advanced Cancers and Rare Tumors at ASCO 2025 emdgroup.com ↗
Data from Phase 3 MANEUVER study demonstrating significant improvements in physical function and symptoms in patients with tenosynovial giant cell tumor (TGCT) treated with pimicotinib, to be featured in oral presentation |
| 2025-05-20 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko’s CSF-1R Inhibitor, Pimicotinib (ABSK021), Granted Priority Review for TGCT by the China NMPA abbisko.com ↗
20 May 2025, Shanghai – Abbisko Therapeutics Co., Ltd. (Abbisko Therapeutics, 02256.HK) today announced that its highly selective small-molecule CSF-1R inhibitor, pimicotinib (ABSK021), has been granted Priority Review status by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of patients with Tenosynovial Giant Cell Tumor (TGCT). |
| 2024-12-09 | Abbisko Therapeutics Co, Ltd | Results 2024 ASH Oral Presentation——Abbisko presents promising preliminary phase 2 study results of pimicotinib in the treatment of Chronic Graft-versus-Host Disease (cGvHD) at the 66th ASH Annual Meeting abbisko.com ↗
Despite most enrolled patients having not yet completed the 6-month treatment cycle required for cGvHD response evaluation, preliminary data from the subset of patients receiving 20mg QD shows that pimicotinib achieved an ORR of 64%. |
| 2024-11-13 | Abbisko Therapeutics Co, Ltd | Results ACoP 2024 ——Abbisko Therapeutics presents results on model-informed dose selection for pimicotinib (ABSK021) abbisko.com ↗
Nov 13, 2024, Abbisko Therapeutics (HKEX: 02256) presented model-informed dose selection results for its self-discovered, orally available, highly selective, and potent small-molecule CSF-1R inhibitor, pimicotinib (ABSK021)，for the treatment of Tenosynovial Giant Cell Tumor (TGCT) at the American Conference on Pharmacometrics (ACoP) 2024. |
| 2024-11-12 | EMD Serono Research & Development Institute, Inc. | Results Pimicotinib Significantly Improved Outcomes for Patients with TGCT in Phase III Trial emdserono.com ↗ |
| 2024-11-12 | Merck KGaA, Darmstadt, Germany | Results Pimicotinib Significantly Improved Outcomes for Patients with TGCT in Phase III Trial emdgroup.com ↗
Phase III MANEUVER trial of pimicotinib met its primary endpoint, demonstrating significant improvement in objective response rate in TGCT-patients. |
| 2024-11-12 | Abbisko Therapeutics Co, Ltd | Results Pimicotinib Significantly Improved Outcomes for Patients with Tenosynovial Giant Cell Tumor in a Global Phase III Trial abbisko.com ↗
The MANEUVER study met the primary endpoint with an objective response rate (ORR) at week 25 of 54.0% compared with 3.2% for placebo (p< 0.0001 ) |
| 2024-04-10 | Abbisko Therapeutics Co, Ltd | Results 2024 AACR | Abbisko Therapeutics Presented 3 Pre-clinical Research Results with Oral and Poster Presentations abbisko.com ↗
In addition, Abbisko has also presented pre-clinical data of its innovative CSF-1R inhibitor pimicotinib（ABSK021）and oral small molecule PD-L1 inhibitor by posters. |
| 2024-03-07 | Abbisko Therapeutics Co, Ltd | Results 2024 AACR | Abbisko Therapeutics will present 3 pre-clinical research results with oral presentation and posters abbisko.com ↗
CSF-1R inhibition with Pimicotinib (ABSK021) enhanced anti-tumor efficacy of KRASG12C inhibitors in preclinical non-small cell lung cancer mouse models |
| 2024-01-09 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutic announces that EMA has granted orphan drug designation for its CSF-1R inhibitor Pimicotinib （ABSK021） abbisko.com ↗
On January 9, 2024, Abbisko Therapeutics (HKEX code: 02256) announced that its investigational innovative CSF-1R inhibitor pimicotinib（ABSK021） has been granted orphan drug designation（ODD） by the European Medicines Agency (EMA) for the treatment of inoperable tenosynovial giant cell tumor (TGCT). |
| 2023-12-14 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Announces that U.S. FDA Has Granted Fast Track Designation for Its CSF-1R Inhibitor Pimicotinib（ABSK021） abbisko.com ↗
Abbisko Therapeutics Co., Ltd. (Abbisko Therapeutics) today announced that its CSF-1R inhibitor pimicotinib（ABSK021）has been granted the fast track designation（FTD） by the U.S. FDA for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. |
| 2023-11-03 | Abbisko Therapeutics Co, Ltd | Results Abbisko presented two clinical updates of Pimicotinib（ABSK021）at the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting abbisko.com ↗
Upon 1-year follow-up, striking improvement in efficacy has been observed with pimicotinib treatment in TGCT patients compared to the 6-month data previously reported in CTOS of last year, with an ORR of 87.5% (28/32, including 3 CR) in the 50 mg QD cohort and 66.7% (8/12, including 2 CR) in the 25 mg QD cohort by IRC based on RECIST 1.1 criteria. |
| 2023-09-11 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Obtained Approval from Europe EMA for Pivotal Global Multi-Center Phase III Clinical Trial of CSF-1R Inhibitor Pimicotinib (ABSK021) abbisko.com ↗ |
| 2023-06-08 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics announces that Europe EMA has granted Priority Medicine designation for its CSF-1R inhibitor Pimicotinib（ABSK021） abbisko.com ↗
Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) today announced that its novel CSF-1R inhibitor Pimicotinib (ABSK021）has been granted the Priority Medicine (PRIME) designation by the European Medicines Agency (EMA) for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. |
| 2023-05-29 | Abbisko Therapeutics Co, Ltd | Results Abbisko to present updated Phase Ib clinical results of Pimicotinib (ABSK021）in patients with advanced TGCT at the 2023 ASCO annual meeting abbisko.com ↗
Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) announced that the updated results of Phase Ib study of CSF-1R inhibitor Pimicotinib (ABSK021) in treating patients with advanced tenosynovial giant cell tumor (“TGCT”), will be presented at the 2023 American Society of Clinical Oncology (“ASCO”) annual meeting held in Chicago, USA from June 2 to June 6, 2023. |
| 2023-04-17 | Abbisko Therapeutics Co, Ltd | Results Abbisko presents 5 research results at the 2023 AACR Annual Meeting abbisko.com ↗
A potent and selective small molecule inhibitor of CSF-1R ABSK021 demonstrates strong efficacy in preclinical models of osteosarcoma |
| 2023-03-16 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Obtained Approval from U.S. FDA for Pivotal Global Multi-center Phase III Clinical Trial of CSF-1R Inhibitor Pimicotinib (ABSK021) abbisko.com ↗
Abbisko Therapeutics Co., Ltd. (HKEX Stock Code: 2256. HK, referred to as “Abbisko Therapeutics” hereafter) announced that the U.S. FDA had approved its CSF-1R inhibitor pimicotinib（ABSK021）for a randomized, double-blind, placebo-controlled, multicenter Phase III clinical study in patients with giant cell tumor of the tendon sheath. |
| 2023-01-30 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics announces that US FDA has granted breakthrough therapy designation for its CSF-1R inhibitor Pimicotinib（ABSK021） abbisko.com ↗
30 Jan 2023, Shanghai – Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) today announced that its CSF-1R inhibitor Pimicotinib（ABSK021）has been granted the breakthrough therapy designation from FDA for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. |
| 2023-01-17 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Obtains Approval from The China NMPA to Conduct a Phase II Clinical Study of Pimicotinib (ABSK021）in cGVHD abbisko.com ↗
today announced that its CSF-1R inhibitor, pimicotinib (ABSK021), has been approved by the National Medical Products Administration (“NMPA”) of the People’s Republic of China for a phase II clinical study in patients with chronic graft-versus-host disease (“cGVHD”). |
| 2022-10-25 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics obtained pivotal Phase III clinical trial approval for CSF-1R inhibitor ABSK021 from the CDE of NMPA abbisko.com ↗
Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) today announced that its CSF-1R inhibitor ABSK021 has been approved by the Center for Drug Evaluation (“CDE”) of the National Medical Products Administration of the People’s Republic of China (“NMPA”) for a randomized, double-blind, placebo-controlled and multicenter Phase III clinical study in patients with tenosynovial giant cell tumor (“TGCT”). |
| 2022-07-20 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics announces China NMPA breakthrough therapy designation granted for its CSF-1R inhibitor ABSK021 abbisko.com ↗
20 July 2022, Shanghai – Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) today announced that its CSF-1R inhibitor ABSK021 had been granted the breakthrough therapy designation from Center for Drug Evaluation, NMPA for the treatment of tenosynovial giant cell tumor (TGCT) that not amenable to surgery. |
| 2022-03-11 | Abbisko Therapeutics Co, Ltd | Results Abbisko Therapeutics Declared Two Next-Generation Precision Oncology Preclinical Candidates and Will Present Multiple Discovery and Translational Research Results at AACR Annual Meeting 2022 abbisko.com ↗
In vivo efficacy screen of a CSF-1R inhibitor ABSK021 in mouse syngeneic tumor models reveals immune features that may predict its therapeutic response |
| 2020-10-29 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Obtained ABSK021 IND Approval in China abbisko.com ↗
Abbisko Therapeutics Co., Ltd. (“Abbisko” hereafter) today announces that it has obtained the regulatory approval of ABSK021, a CSF-1R small molecule antagonist, by National Medical Products Administration (NMPA) of Chin上a, and will initiate a phase I clinical study in subjects with advanced solid tumors. |
| 2019-08-19 | Abbisko Therapeutics Co, Ltd | Regulatory Abbisko Therapeutics Announces Initiation of Phase 1 Trial for ABSK021, its Selective CSF-1R Small Molecule Inhibitor abbisko.com ↗
Abbisko Therapeutics, a clinical-stage biopharmaceutical company focused on creating innovative medicine for unmet medical needs in China and around the world, today announced that it has received regulatory approval from US FDA to initiate its Phase 1 trial for ABSK021, a CSF-1R small molecule inhibitor for treating multiple types of tumors, and expects to start dosing patients shortly. |
All press releases naming this drug 62 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pimicotinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07707882 ↗ |
| Known as | ABSK-021 FREE BASE ANHYDROUS | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314535 ↗ |
| Known as | ABSK-021-0 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314535 ↗ |
| Known as | ABSK-021-0 FREE BASE ANHYDROUS | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314535 ↗ |
| Known as | ABSK-021-7 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314535 ↗ |
| Known as | ABSK021 | “The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab in patients with...” NCT06111274 ↗7“The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in patients with Tenosynovial Giant Cell Tumor (TGCT).” NCT05804045 ↗ “single 10mg Oral administration of ABSK021 at C1D1” NCT06089733 ↗ “Drug: Pimicotinib（ABSK021）” NCT06186583 ↗ |
| Known as | ABSK021-NX | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314535 ↗ |
| Known as | ASYM-132018 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314535 ↗ |
| Known as | ASYM-133040 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314535 ↗ |
| Known as | PIMICOTINIB HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314535 ↗ |
| Action | Inhibit | “pimicotinib, a highly selective, potent, colony-stimulating factor-1 receptor inhibitor” PMID 41796601 ↗ Mar 2026 |
| Modality | Small molecule | “Pimicotinib is an orally available, highly selective and potent small molecule CSF-1 receptor (CSF-1R) inhibitor” PMID 39287124 ↗ Sep 2024 |
| Route | Oral | “oral ABSK021” NCT04192344 ↗ |