Clinical Trials

Numerous clinical trials evaluate the therapeutic and diagnostic applications of papain across diverse medical disciplines. Encompassing Phase 1 and Phase 2 protocols sponsored by academic institutions and corporate entities, these evaluations focus on conditions such as dental caries, molar incisor hypomineralization, lower extremity chronic venous ulcers, itch, and prostate adenocarcinoma. Across these studies, recruitment statuses are variously recorded as completed, terminated, or unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05983900 UNKNOWN
Dental Caries
Alexandria University
 2023-04-01
NCT06412731 COMPLETED
Dental Caries in Children
Al-Mustansiriyah University
 2024-01-02
NCT04252625 TERMINATED
Prostate Adenocarcinoma
University of Utah
 2022-11-14 PHASE2
NCT05733923 COMPLETED
Dental Caries
Damascus University
 2023-02-25
NCT04554888 COMPLETED
Itch
Aalborg University
 2022-03-01
NCT04711044 COMPLETED
Itch
Aalborg University
 2021-02-01
NCT04515056 COMPLETED
Papain; Itch; Skin Prick Test (SPT)
Aalborg University
 2020-09-01
NCT04710927 COMPLETED
Molar Incisor Hypomineralization; Dental Caries; Hypomineralization of Enamel
University of Malaya
 2019-12-01
NCT03753958 UNKNOWN
Peri-Implantitis
University of Nove de Julho
 2019-01-02 PHASE2
NCT03408626 UNKNOWN
Microbial Colonization
Cairo University
 2019-03-01
NCT02015195 COMPLETED
Jellyfish Stings
Stanford University
 2013-06
NCT01811420 COMPLETED
Dental Caries
University of Nove de Julho
 2009-03
NCT00485329 COMPLETED
Lower Extremity Chronic Venous Ulcers
EnzySurge
 2007-07 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2024-04-02)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Papain acts as a sulfhydryl cysteine protease that hydrolyzes peptide bonds in proteins, resulting in the breakdown of the intercellular matrix and necrotic tissue components. This localized enzymatic cleavage promotes selective tissue debridement, providing therapeutic relevance in clinical settings such as chemomechanical dental caries removal and chronic ulcer management.

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.