Clinical Trials

Pamapimod, a small-molecule inhibitor commercially sponsored by Kinarus AG, has been evaluated in a clinical trial for the treatment of COVID-19. Designed as a double-blind, randomized, placebo-controlled Phase II study, the research aimed to evaluate accelerated symptom termination in affected patients. However, recruitment for the trial was officially terminated, and no other clinical trials investigating Pamapimod are currently on record.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05659459 TERMINATED
COVID-19
Kinarus AG
 2022-08-25 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-03-14)

Check the Pamapimod product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pamapimod selectively binds to and inhibits p38α and p38β mitogen-activated protein kinases, blocking downstream phosphorylation cascades and preventing the cellular production of key pro-inflammatory cytokines. By suppressing p38 MAPK-mediated inflammatory signaling, the compound attenuates hyperinflammatory responses, providing direct therapeutic relevance for inflammatory viral respiratory conditions such as COVID-19.

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.