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Artrodar (DIACEREIN)
Artrodar (generic name: DIACEREIN) is a diacerein drug. It is currently in Phase 3 development.
Artrodar works by inhibiting the enzyme N-acylethanolamine-hydrolyzing acid amidase, which plays a role in the breakdown of joint cartilage.
Artrodar (DIACEREIN) is a small molecule diacerein drug targeting N-acylethanolamine-hydrolyzing acid amidase. It is used to treat osteoarthritis, although its commercial status and FDA approval are unknown. As a diacerein, Artrodar works by inhibiting the breakdown of joint cartilage and reducing inflammation. The exact pharmacokinetic properties of Artrodar, including half-life and bioavailability, are not well-documented. Further research is needed to fully understand its safety and efficacy.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | DIACEREIN |
|---|---|
| Drug class | diacerein |
| Target | Caspase-3, Caspase-7, N-acylethanolamine-hydrolyzing acid amidase |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | Phase 3 |
Mechanism of action
Think of joint cartilage like a sponge that absorbs shock and helps joints move smoothly. When this sponge breaks down, it can cause pain and stiffness. Artrodar helps slow down the breakdown of this sponge by blocking the enzyme that breaks it down, which can help reduce joint pain and inflammation.
Approved indications
Common side effects
- Cerebral artery thrombosis
- Brain scan abnormal
- Areflexia
- Ischaemic stroke
- Hemiplegia
- Facial paralysis
- Respiratory distress
- Disease recurrence
Key clinical trials
- Topical Diacerein in Psoriasis Vulgaris (PHASE4)
- An International, Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled, Phase 2/3 Study With Open-Label Extension Evaluating the Efficacy and Safety of Diacerein 1% Ointment for the Treatment of Generalized Epidermolysis Bullosa Simplex (EBS) (PHASE2,PHASE3)
- Diacerein in the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease (NA)
- A Phase II Clinical Study of AC-201 Tablets in Subjects With Plaque Psoriasis (PHASE2)
- Efficacy of Diacerein Supplementation on Interleukin-1β, Hs-CRP, TNF-α Levels and Glycemic Control in Uncontrolled Type 2 Diabetes Mellitus Patients at Dr. Mohammad Hoesin General Hospital Palembang (PHASE2,PHASE3)
- Evaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients (PHASE3)
- Bioequivalence Study of Diacerein 50 mg Capsule in Healthy Thai Volunteers (PHASE1)
- Effect of Diacerein vs Celecoxib on Symptoms and Structural Changes in Symptomatic Knee Osteoarthritis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Artrodar CI brief — competitive landscape report
- Artrodar updates RSS · CI watch RSS
Frequently asked questions about Artrodar
What is Artrodar?
How does Artrodar work?
What is the generic name of Artrodar?
What drug class is Artrodar in?
What development phase is Artrodar in?
What are the side effects of Artrodar?
What does Artrodar target?
Related
- Drug class: All diacerein drugs
- Target: All drugs targeting Caspase-3, Caspase-7, N-acylethanolamine-hydrolyzing acid amidase
- Therapeutic area: All drugs in Pain
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing