Drugs / Diacerein
last change Jun 2026 re-read 9 days ago

Diacerein

also known as AC-201 · AC-203 · AC-201 CR tablet · Artrodar · DAR · Diacerhein

Small molecule targets IL1B, JAK1, TYK2 via inhibition

Developed for
osteoarthritis, knee · epidermolysis bullosa simplex · type 2 diabetes mellitus · gout · psoriasis · bullous pemphigoid · hemophilic arthropathy · hyperglycemia
+11 more · inherited epidermolysis bullosa · metabolic dysfunction-associated steatotic liver disease · NAFLD1 · obesity disorder · osteoarthritis · osteoarthritis, hand · osteoarthritis, hip · primary thrombocytopenia · rheumatoid arthritis · thrombocytopenia · COVID-19
Investigated by
Castle Creek Pharmaceuticals, LLC · TWi Biotechnology, Inc. · Laboratoires NEGMA · TRB Chemedica · Accro Bioscience (Suzhou) Limited · Anhui Medical University
+24 more · ArthroLab Inc. · Cairo University · Coordinación de Investigación en Salud, Mexico · Federal University of Rio de Janeiro · Government Medical College, Amritsar · Hongyan Wu · Indonesia Endowment Fund for Education (LPDP), Ministry of Finance Republik of Indonesia · Korea University Guro Hospital · Myungmoon Pharm. Co. · National Council of Science and Technology, Mexico · Qilu Hospital of Shandong University · Ramathibodi Hospital · Rio de Janeiro State Research Supporting Foundation (FAPERJ) · Seoul National University Hospital · Shandong University · Shenzhen Second People's Hospital · TKL Research, Inc. · TRB Chemedica International SA · The Affiliated Hospital of the Chinese Academy of Military Medical Sciences · The First Affiliated Hospital of Dalian Medical University · Tongji Hospital · Universitas Sriwijaya · Whan-Seok Choi · Zhejiang Provincial Hospital of TCM

Trials 33

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT03472287 May 2018 → Jan 2019 epidermolysis bullosa dystrophica, epidermolysis bullosa simplex, junctional epidermolysis bullosa Castle Creek Pharmaceuticals, LLC Completed No outcome recorded
Phase 1 NCT03472547 Jan → Mar 2018 — Castle Creek Pharmaceuticals, LLC Completed No outcome recorded
Phase 1 NCT03472534 Jan 2018 — Castle Creek Pharmaceuticals, LLC Completed No outcome recorded
Phase 1 NCT03473197 Jan → Mar 2018 — Castle Creek Pharmaceuticals, LLC Completed No outcome recorded
Phase 1 NCT03473184 Dec 2017 — Castle Creek Pharmaceuticals, LLC Completed No outcome recorded
Phase 213 trials · 1 met primary · 3 missed
Phase 2 NCT06972888 Apr 2024 → Mar 2025 psoriasis Accro Bioscience (Suzhou) Limited Completed No outcome recorded
Phase 2 NCT04917679 Sep 2020 → Dec 2021 primary thrombocytopenia Qilu Hospital of Shandong University Completed No outcome recorded
Phase 2 NCT03754634 May 2019 → Jun 2020 thrombocytopenia Shandong University Completed No outcome recorded
Phase 2 NCT03468322 Oct 2018 → Apr 2019 inherited epidermolysis bullosa TWi Biotechnology, Inc. Completed No outcome recorded
Phase 2 NCT03389308 Dec 2017 → Apr 2020 epidermolysis bullosa simplex Castle Creek Pharmaceuticals, LLC Completed No outcome recorded
Phase 2 NCT03286582 Sep 2017 → Dec 2018 bullous pemphigoid TWi Biotechnology, Inc. Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT03154333 Jun 2017 → Oct 2018 epidermolysis bullosa simplex Castle Creek Pharmaceuticals, LLC Terminated Missed primary
Phase 2 NCT02994147 Mar 2017 → Apr 2019 hemophilic arthropathy TWi Biotechnology, Inc. Completed No outcome recorded
Phase 2 NCT02287818 Dec 2014 → Oct 2016 gout TWi Biotechnology, Inc. Completed No outcome recorded
Phase 2 NCT01712204 Jan → Sep 2013 gout TWi Biotechnology, Inc. Completed Missed primary
Phase 2/32 trials
Phase 2/3 NCT06912035 Jun → Nov 2024 hyperglycemia, type 2 diabetes mellitus Universitas Sriwijaya Completed No outcome recorded
Phase 2/3 NCT06073132 Apr 2024 → Jun 2026 overdue epidermolysis bullosa simplex TWi Biotechnology, Inc. Active not recruiting No outcome recorded
Phase 34 trials · 3 met primary
Phase 3 NCT04318041 Nov 2020 → Dec 2026 expected osteoarthritis, knee TRB Chemedica Active not recruiting No outcome recorded
Phase 3 NCT02688400 May 2016 → Jun 2018 osteoarthritis, knee TRB Chemedica International SA Completed Met primary
Phase 3 NCT02242149 Oct 2014 → Jan 2017 NAFLD1, type 2 diabetes mellitus Federal University of Rio de Janeiro Completed Met primary
Phase 3 NCT00451360 Mar 1993 → Apr 1997 osteoarthritis, hip Laboratoires NEGMA Completed Met primary
Phase 48 trials · 1 missed
Phase 4 NCT07352306 Feb 2026 → Feb 2027 expected psoriasis Cairo University Not yet recruiting No outcome recorded
Phase 4 NCT03404479 Jan 2018 → Jan 2019 osteoarthritis, knee Whan-Seok Choi Unknown No outcome recorded
Phase 4 NCT01906801 Jul 2013 → Oct 2014 osteoarthritis, knee Ramathibodi Hospital Completed Missed primary
Phase 4 NCT02060552 Jan 2013 → Mar 2014 gout Tongji Hospital Completed No outcome recorded
Phase 4 NCT00685542 Jun 2008 → Oct 2009 osteoarthritis, hand Seoul National University Hospital Completed No outcome recorded
Phase 4 NCT00440661 Mar 2007 → Oct 2008 osteoarthritis Laboratoires NEGMA Completed No outcome recorded
Phase 4 NCT01120015 Jan 2007 → Jun 2008 osteoarthritis, knee Government Medical College, Amritsar Completed No outcome recorded
Phase 4 NCT00445276 Nov 2005 → Sep 2006 osteoarthritis, knee Laboratoires NEGMA Completed No outcome recorded
Phase not applicable1 trial
— NCT07199933 Oct 2025 → Oct 2026 expected metabolic dysfunction-associated steatotic liver disease Hongyan Wu Not yet recruiting No outcome recorded
Comparator or background therapy4 trials
Phase 2 NCT05226754 Comparator Apr 2022 → Jun 2023 COVID-19 University of Campinas, Brazil Unknown No outcome recorded
Phase 2 NCT02177643 Comparator Jan 2013 → Aug 2016 type 2 diabetes mellitus University of Campinas, Brazil Unknown No outcome recorded
Phase 2 NCT03208309 Comparator Jan 2013 → Aug 2015 type 2 diabetes mellitus ANS Pharma Completed No outcome recorded
Phase 3 NCT07549386 Comparator May 2024 → Mar 2025 osteoarthritis Laboratorios Liomont Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2025-08-29 Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. Fosun Pharma Gains Exclusive Rights for Accro's Novel Small-Molecule Drug Candidate AC-201 in Greater China fosunpharma.com ↗

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 39 sources stand behind the page.

FieldValueCited text
Known as diacerein “AC-203 (diacerein 1% ointment) is a topical formulation of diacerein, well-known for its ability to inhibit IL-1β and other proinflammatory cytokines.” NCT06073132 ↗
28

“Diacerein (Artrodar ®) participants take 1x1 with evening meal for 1 month” NCT04318041 ↗

NCT01120015 ↗

NCT07199933 ↗

NCT03472287 ↗

NCT03154333 ↗

NCT03208309 ↗

NCT02688400 ↗

NCT00451360 ↗

NCT03473184 ↗

NCT07352306 ↗

Show 18 more sources

Known as AC-201 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01276106 ↗
4

NCT02287818 ↗

NCT01712204 ↗

NCT02994147 ↗

NCT06972888 ↗

Known as AC-201 CR tablet “AC-201 CR tablet” NCT02287818 ↗
Known as AC-203 “AC-203 (diacerein 1% ointment) is a topical formulation of diacerein, well-known for its ability to inhibit IL-1β and other proinflammatory cytokines.” NCT06073132 ↗
2

NCT03468322 ↗

NCT03286582 ↗

Known as Artrodar “Diacerein (Artrodar ®) participants take 1x1 with evening meal for 1 month” NCT04318041 ↗
Known as DAR “Diacerein (DAR) is an anthraquinone derivative drug whose active metabolite is rhein.” PMID 32534337 ↗ Jun 2020
Known as Diacerhein ClinicalTrials.gov intervention name — accepted as the source's own label NCT00440661 ↗
Action Inhibit “diacerein, an interleukin-1beta inhibitor” PMID 11710710 ↗ Nov 2001
Modality Small molecule “Diacerein, a purified compound with anthraquinonic structure” NCT01120015 ↗
Route Oral “oral IL-1beta inhibitor AC-201” NCT01276106 ↗
Target IL1B “AC-201 is an IL-1β modulator” NCT01712204 ↗