Multiple clinical trials across Phase 1, Phase 2, and Phase 3 development are evaluating pimicotinib for conditions including tenosynovial giant cell tumor, advanced pancreatic cancer, and chronic graft-versus-host disease, as well as pharmacokinetic profiles in healthy and hepatically impaired subjects. Led by sponsors such as Abbisko Therapeutics, Merck Healthcare KGaA, and the Second Affiliated Hospital of Zhejiang University School of Medicine, the trial portfolio ranges in recruitment status from completed pharmacokinetic studies to actively enrolling Phase 2 trials.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07499362 | RECRUITING | Tenosynovial Giant Cell Tumor |
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany |
2026-03-26 | PHASE2 |
| NCT07707882 | NOT_YET_RECRUITING | Tenosynovial Giant Cell Tumor, Diffuse |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2027-10-01 | PHASE2 |
| NCT06186804 | ENROLLING_BY_INVITATION | cGvHD |
Abbisko Therapeutics Co, Ltd |
2023-05-30 | PHASE2 |
| NCT06111274 | RECRUITING | Advanced Pancreatic Cancer |
Abbisko Therapeutics Co, Ltd |
2023-10-17 | PHASE2 |
| NCT07210996 | COMPLETED | Pharmacokinetics in Healthy Volunteers |
Abbisko Therapeutics Co, Ltd |
2025-09-12 | PHASE1 |
| NCT06884072 | ACTIVE_NOT_RECRUITING | Healthy Subjects |
Abbisko Therapeutics Co, Ltd |
2025-04-08 | PHASE1 |
| NCT07126249 | COMPLETED | Pharmacokinetics |
Abbisko Therapeutics Co, Ltd |
2025-05-13 | PHASE1 |
| NCT06779253 | COMPLETED | Healthy Subjects |
Abbisko Therapeutics Co, Ltd |
2025-03-14 | PHASE1 |
| NCT06694948 | COMPLETED | Pharmacokinetics |
Abbisko Therapeutics Co, Ltd |
2024-12-10 | PHASE1 |
| NCT06562946 | COMPLETED | Pharmacokinetics |
Abbisko Therapeutics Co, Ltd |
2024-09-20 | PHASE1 |
| NCT05804045 | ACTIVE_NOT_RECRUITING | Tenosynovial Giant Cell Tumor; Pigmented Villonodular Synovitis; Giant Cell Tumor of Tendon Sheath |
Abbisko Therapeutics Co, Ltd |
2023-04-27 | PHASE3 |
| NCT06186583 | COMPLETED | Healthy Subjects |
Abbisko Therapeutics Co, Ltd |
2023-12-13 | PHASE1 |
| NCT06111274 | Recruiting | Advanced Pancreatic Cancer |
Abbisko Therapeutics Co Ltd |
2023-10-17 | Phase 2 |
(data from https://clinicaltrials.gov, updated on 2026-08-10)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).