Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials, primarily sponsored by Boehringer Ingelheim, evaluated the pharmacokinetics, safety, and efficacy of Doramapimod (BIRB 796). Phase 1 trials assessed single rising doses and endotoxin-induced inflammation in healthy cohorts, whereas Phase 2 trials evaluated dosing regimens in patients with rheumatoid arthritis, psoriasis, and Crohn's disease. While several trials were completed, others were terminated during Phase 2 development.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02209792 TERMINATED
Crohn Disease
Boehringer Ingelheim
 2001-10 PHASE2
NCT02214888 TERMINATED
Arthritis, Rheumatoid
Boehringer Ingelheim
 2003-05 PHASE2
NCT02211144 COMPLETED
Healthy
Boehringer Ingelheim
 2002-03 PHASE1
NCT02211885 COMPLETED
Healthy
Boehringer Ingelheim
 2002-10 PHASE1
NCT02211885 Completed
Healthy
Boehringer Ingelheim
 2002-10 Phase 1
NCT02209753 COMPLETED
Psoriasis
Boehringer Ingelheim
 2001-06 PHASE2
NCT02209779 COMPLETED
Arthritis, Rheumatoid
Boehringer Ingelheim
 2001-05 PHASE2
NCT02209831 COMPLETED
Healthy
Boehringer Ingelheim
 2001-11 PHASE1
NCT02209805 COMPLETED
Healthy
Boehringer Ingelheim
 2001-01 PHASE1
NCT02211157 COMPLETED
Healthy
Boehringer Ingelheim
 2000-03 PHASE1
NCT02211170 COMPLETED
Healthy
Boehringer Ingelheim
 2000-02 PHASE1
NCT02208856 COMPLETED
Healthy
Boehringer Ingelheim
 1999-09 PHASE1

(data from https://clinicaltrials.gov, updated on 2014-08-06)

Check the Doramapimod (BIRB 796) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Doramapimod (BIRB 796) is a potent pan-p38 mitogen-activated protein kinase (MAPK) inhibitor that binds allosterically to p38 MAPK isoforms, effectively blocking downstream phosphorylation of substrates such as heat shock protein 27 (Hsp27) and suppressing pro-inflammatory cytokine production. By inhibiting p38 MAPK signaling, Doramapimod reduces cellular inflammatory responses, providing therapeutic relevance for inflammatory disorders such as rheumatoid arthritis, psoriasis, and Crohn's disease.

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.