Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate diacerein across diverse inflammatory and metabolic disorders, including knee and hand osteoarthritis, epidermolysis bullosa simplex, primary gout, type 2 diabetes mellitus, non-alcoholic fatty liver disease, and COVID-19. Sponsored by academic centers and pharmaceutical organizations—such as Castle Creek Pharmaceuticals LLC, TRB Chemedica International SA, and Seoul National University Hospital—these studies report active, completed, or terminated recruitment statuses. Completed trials have specifically focused on outcomes ranging from symptom management in osteoarthritis to glycemic control and hepatic fat accumulation in metabolic disease.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07352306 NOT_YET_RECRUITING
Psoriasis Vulgaris
Cairo University
 2026-02-01 PHASE4
NCT04318041 RECRUITING
Knee Osteoarthritis
TRB Chemedica
 2020-11-22 PHASE3
NCT07199933 NOT_YET_RECRUITING
MAFLD
Hongyan Wu
 2025-10-01
NCT06073132 ACTIVE_NOT_RECRUITING
Generalized Epidermolysis Bullosa Simplex
TWi Biotechnology, Inc.
 2024-04-04 PHASE2; PHASE3
NCT07549386 COMPLETED
Pain Management; Osteoarthritis
Laboratorios Liomont
 2024-05-24 PHASE3
NCT06912035 COMPLETED
Uncontrolled Diabetes; Diabetes Mellitus Type 2
Universitas Sriwijaya
 2024-06-21 PHASE2; PHASE3
NCT06308068 UNKNOWN
Healthy Volunteer
International Bio service
 2024-07-30 PHASE1
NCT05226754 UNKNOWN
COVID-19
University of Campinas, Brazil
 2022-04-01 PHASE2
NCT04917679 COMPLETED
Thrombocytopenia
Qilu Hospital of Shandong University
 2020-09-01 PHASE2
NCT03754634 COMPLETED
Thrombocytopenia
Shandong University
 2019-05-01 PHASE2
NCT03389308 COMPLETED
Epidermolysis Bullosa; Epidermolysis Bullosa Simplex
Castle Creek Pharmaceuticals, LLC
 2017-12-01 PHASE2
NCT03472287 COMPLETED
Epidermolysis Bullosa (EB); Epidermolysis Bullosa Simplex; Dystrophic Epidermolysis Bullosa; Junctional Epidermolysis Bullosa
Castle Creek Pharmaceuticals, LLC
 2018-05-18 PHASE1
NCT03404479 UNKNOWN
Knee Osteoarthritis
Whan-Seok Choi
 2018-01-25 PHASE4
NCT03154333 TERMINATED
Epidermolysis Bullosa Simplex
Castle Creek Pharmaceuticals, LLC
 2017-06-01 PHASE2
NCT02688400 COMPLETED
Osteoarthritis; Osteoarthritis, Knee
TRB Chemedica International SA
 2016-05 PHASE3
NCT03472287 Completed
Epidermolysis Bullosa (EB)|Epidermolysis Bullosa Simplex|Dystrophic Epidermolysis Bullosa|Junctional Epidermolysis Bullosa
Castle Creek Pharmaceuticals LLC
 2018-05-18 Phase 1
NCT03473197 COMPLETED
Healthy
Castle Creek Pharmaceuticals, LLC
 2018-01-08 PHASE1
NCT03472547 COMPLETED
Healthy
Castle Creek Pharmaceuticals, LLC
 2018-01-15 PHASE1
NCT03472534 COMPLETED
Healthy
Castle Creek Pharmaceuticals, LLC
 2018-01-09 PHASE1
NCT03473184 COMPLETED
Healthy
Castle Creek Pharmaceuticals, LLC
 2017-12-12 PHASE1
NCT02242149 COMPLETED
Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease
Universidade Federal do Rio de Janeiro
 2014-10-14 PHASE3
NCT02177643 UNKNOWN
Diabetes-Related Complications; Diabetes Mellitus, Type 2; Insulin Resistance
University of Campinas, Brazil
 2013-01 PHASE2
NCT03208309 COMPLETED
Complications of Diabetes Mellitus; Diabetes Mellitus; Diabetes Mellitus, Type 2
ANS Pharma
 2013-01 PHASE2
NCT01906801 COMPLETED
Osteoarthritis; Glucosamine; Diacerein
Ramathibodi Hospital
 2013-07 PHASE4
NCT02060552 COMPLETED
Primary Gout
Tongji Hospital
 2013-01 PHASE4
NCT01264211 COMPLETED
Rheumatoid Arthritis
TRB Chemedica
 2010-10 PHASE2
NCT00685542 COMPLETED
Osteoarthritis
Seoul National University Hospital
 2008-06 PHASE4
NCT01120015 COMPLETED
Osteoarthritis; Osteoarthritis, Knee
Government Medical College, Amritsar
 2007-01 PHASE4
NCT00445276 COMPLETED
Knee Osteoarthritis
Laboratoires NEGMA
 2005-11 PHASE4
NCT00451360 COMPLETED
Hip Osteoarthritis
Laboratoires NEGMA
 1993-03 PHASE3
NCT01298882 COMPLETED
Type 2 Diabetes Mellitus; Overweight; Obesity
Coordinación de Investigación en Salud, Mexico
 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-01-20)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Diacerein inhibits the production of the pro-inflammatory cytokine interleukin-1 beta (IL-1β), thereby blocking downstream signaling cascades and the expression of catabolic matrix-degrading enzymes. This reduction in cellular inflammation and tissue breakdown provides therapeutic efficacy against clinical conditions such as osteoarthritis, epidermolysis bullosa, and type 2 diabetes.

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.