Clinical Trials

Multiple clinical trials, comprising an Early Phase 1 trial and a Phase 2 trial sponsored by medical centers including Jinnah Postgraduate Medical Centre and Hunt Regional Medical Center, are evaluating dapsone across dermatological and respiratory indications. Investigated conditions include moderate acne vulgaris, which has reached completed status, and SARS-CoV-2 infection complicated by hypoxia and acute respiratory distress syndrome, listed with an unknown recruitment status. Together, these clinical investigations reflect interest in evaluating the drug's therapeutic potential for inflammatory skin conditions as well as viral-induced acute respiratory complications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05926869 Completed
Acne Vulgaris
Jinnah Postgraduate Medical Centre
 2022-08-01 Phase 2
NCT04918914 Unknown status
SARS-CoV-2|Hypoxia|ARDS
Hunt Regional Medical Center
 2020-10-18 Early Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dapsone competitively inhibits bacterial dihydropteroate synthase to block folate synthesis and additionally suppresses myeloperoxidase activity and neutrophil chemotaxis. This dual antimicrobial and immunomodulatory action reduces reactive oxygen species production and localized tissue inflammation, providing a rational basis for its clinical application in acne vulgaris and hyperinflammatory respiratory conditions associated with SARS-CoV-2.

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.