Clinical Trials

Multiple clinical trials, primarily Phase I and Phase II studies, have evaluated the therapeutic efficacy and safety of Ossirene (AS101) across diverse dermatological, oncological, hematological, and infectious indications. These investigations addressed conditions including HIV, acute myeloid leukemia, myelodysplastic syndrome, chemotherapy-induced thrombocytopenia, psoriasis, atopic dermatitis, and external genital warts. Sponsored by academic, healthcare, and pharmaceutical organizations—such as BioMAS Ltd, Wyeth (Pfizer), Rabin Medical Center, and NIAID—the studies reflect varying recruitment statuses ranging from completed to terminated, suspended, or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03216538 COMPLETED
Neovascular Age-related Macular Degeneration
Feramda
 2018-10-08 PHASE1; PHASE2
NCT01943630 UNKNOWN
External Genital Warts
BioMAS Ltd
 2015-01 PHASE2
NCT01010373 SUSPENDED
Acute Myeloid Leukemia; Myelodysplastic Syndrome
BioMAS Ltd
 2015-01 PHASE2
NCT01943630 Unknown status
External Genital Warts
BioMAS Ltd
 2015-01 Phase 2
NCT01010373 Suspended
Acute Myeloid Leukemia|Myelodysplastic Syndrome
BioMAS Ltd
 2015-01 Phase 2
NCT01555112 COMPLETED
Wart; External Genital Organs; Condyloma Acuminata
BioMAS Ltd
 2012-03 PHASE1; PHASE2
NCT00927212 TERMINATED
Atopic Dermatitis
BioMAS Ltd
 2009-06 PHASE2
NCT00926354 TERMINATED
Chemotherapy Induced Thrombocytopenia
BioMAS Ltd
 2009-08 PHASE2
NCT00788424 WITHDRAWN
Mild to Moderate Psoriasis
BioMAS Ltd
 2008-11 PHASE2
NCT00418249 UNKNOWN
Alopecia
Rabin Medical Center
 PHASE2
NCT00002033 COMPLETED
HIV Infections
Wyeth is now a wholly owned subsidiary of Pfizer
NCT00002013 COMPLETED
HIV Infections
Wyeth is now a wholly owned subsidiary of Pfizer
NCT00001006 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002266 COMPLETED
HIV Infections
Wyeth is now a wholly owned subsidiary of Pfizer

(data from https://clinicaltrials.gov, updated on 2020-11-04)

Check the Ossirene (AS101) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ossirene (AS101) directly inhibits interleukin-1 beta (IL-1β) converting enzyme, thereby preventing the proteolytic cleavage and maturation of precursor pro-inflammatory cytokines. This suppression of downstream inflammatory mediators suppresses hyper-active immune responses and cellular toxicity, establishing its biological relevance in clinical trial investigations for inflammatory skin disorders like atopic dermatitis and hematological malignancies.

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.