Clinical Trials

Several clinical trials sponsored by Celgene and Bristol-Myers Squibb have evaluated gamcemetinib (CC-99677), an oral MK2 inhibitor targeting inflammatory conditions. The development program features completed Phase 1 studies in healthy volunteers to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and drug metabolism. Additionally, a Phase 2 trial evaluating efficacy and safety in patients with ankylosing spondylitis was terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04947579 TERMINATED
Spondylitis, Ankylosing
Celgene
 2021-08-25 PHASE2
NCT05284890 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2022-05-12 PHASE1
NCT05284890 Completed
Healthy Volunteers
Bristol-Myers Squibb
 2022-05-12 Phase 1
NCT04958291 COMPLETED
Healthy Volunteers
Celgene
 2021-08-03 PHASE1
NCT04718636 COMPLETED
Healthy Volunteers
Celgene
 2020-09-30 PHASE1
NCT04958291 Completed
Healthy Volunteers
Celgene
 2021-08-03 Phase 1
NCT04268394 COMPLETED
Healthy Volunteer
Celgene
 2020-03-13 PHASE1
NCT03554993 COMPLETED
Healthy Volunteer
Celgene
 2018-05-23 PHASE1
NCT03554993 Completed
Healthy Volunteer
Celgene
 2018-05-23 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-01)

Check the Gamcemetinib (CC-99677) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gamcemetinib acts as a potent, covalent, and irreversible inhibitor of mitogen-activated protein kinase-activated protein kinase-2 (MK2), binding directly to the kinase to block downstream p38 MAPK signal transduction and inhibit pro-inflammatory cytokine production. By suppressing MK2-mediated cellular inflammatory cascades, gamcemetinib reduces cytokine-driven pathological tissue inflammation, providing the mechanistic basis for its clinical investigation in inflammatory conditions such as ankylosing spondylitis.

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>).

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Note: Technical data last updated: Sep 1, 2026.