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Diclofenac 50
Diclofenac 50 is a Nonsteroidal anti-inflammatory drug (NSAID) Small molecule drug developed by Grünenthal GmbH. It is currently in Phase 3 development for Acute pain (postoperative, dental, musculoskeletal), Chronic inflammatory conditions (rheumatoid arthritis, osteoarthritis), Dysmenorrhea. Also known as: Voltaren (Registered Trademark) (diclofenac enteric-coated tablet).
Diclofenac inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain.
Diclofenac inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain. Used for Acute pain (postoperative, dental, musculoskeletal), Chronic inflammatory conditions (rheumatoid arthritis, osteoarthritis), Dysmenorrhea.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | Diclofenac 50 |
|---|---|
| Also known as | Voltaren (Registered Trademark) (diclofenac enteric-coated tablet) |
| Sponsor | Grünenthal GmbH |
| Drug class | Nonsteroidal anti-inflammatory drug (NSAID) |
| Target | COX-1, COX-2 |
| Modality | Small molecule |
| Therapeutic area | Pain Management, Rheumatology, Inflammation |
| Phase | Phase 3 |
Mechanism of action
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that non-selectively inhibits both COX-1 and COX-2 enzymes. By blocking prostaglandin production, it reduces inflammatory mediators and provides analgesic and antipyretic effects. It is commonly used for acute and chronic pain management, particularly in musculoskeletal and inflammatory conditions.
Approved indications
- Acute pain (postoperative, dental, musculoskeletal)
- Chronic inflammatory conditions (rheumatoid arthritis, osteoarthritis)
- Dysmenorrhea
Common side effects
- Gastrointestinal upset (nausea, dyspepsia, abdominal pain)
- Headache
- Dizziness
- Increased risk of cardiovascular events
- Increased risk of gastrointestinal bleeding
- Renal impairment
Key clinical trials
- KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism (NA)
- Helping Osteoarthritis Patients to Walk With NSAID (PHASE4)
- Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery (NA)
- Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery (NA)
- A Comparison of Recovery After Impacted Wisdom Tooth Removal (PHASE3)
- The Effect of Three Different Medications on Anesthetic Success and Postoperative Pain (NA)
- Evaluation of the Efficacy of Diclofenac Potassium and Rimegepant for the Acute Treatment of Migraine (PHASE4)
- Effect of DCS on Post-Endodontic Pain (NA)
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:
- Diclofenac 50 CI brief — competitive landscape report
- Diclofenac 50 updates RSS · CI watch RSS
- Grünenthal GmbH portfolio CI
Frequently asked questions about Diclofenac 50
What is Diclofenac 50?
How does Diclofenac 50 work?
What is Diclofenac 50 used for?
Who makes Diclofenac 50?
Is Diclofenac 50 also known as anything else?
What drug class is Diclofenac 50 in?
What development phase is Diclofenac 50 in?
What are the side effects of Diclofenac 50?
What does Diclofenac 50 target?
Related
- Drug class: All Nonsteroidal anti-inflammatory drug (NSAID) drugs
- Target: All drugs targeting COX-1, COX-2
- Manufacturer: Grünenthal GmbH — full pipeline
- Therapeutic area: All drugs in Pain Management, Rheumatology, Inflammation
- Indication: Drugs for Acute pain (postoperative, dental, musculoskeletal)
- Indication: Drugs for Chronic inflammatory conditions (rheumatoid arthritis, osteoarthritis)
- Indication: Drugs for Dysmenorrhea
- Also known as: Voltaren (Registered Trademark) (diclofenac enteric-coated tablet)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing