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IV Diclofenac
IV Diclofenac is a Nonsteroidal anti-inflammatory drug (NSAID) Small molecule drug developed by Pfizer. It is currently in Phase 3 development for Acute postoperative pain, Acute migraine headache, Moderate to severe acute pain.
Diclofenac inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation, pain, and fever.
Diclofenac inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation, pain, and fever. Used for Acute postoperative pain, Acute migraine headache, Moderate to severe acute pain.
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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. -
Big-pharma sponsor
+3.0pp
Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | IV Diclofenac |
|---|---|
| Sponsor | Pfizer |
| Drug class | Nonsteroidal anti-inflammatory drug (NSAID) |
| Target | COX-1, COX-2 |
| Modality | Small molecule |
| Therapeutic area | Pain Management, Rheumatology, Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that non-selectively blocks COX-1 and COX-2 enzymes. By inhibiting prostaglandin production, it reduces inflammatory mediators and provides analgesic and antipyretic effects. The intravenous formulation allows for rapid onset of action in acute pain and inflammatory conditions.
Approved indications
- Acute postoperative pain
- Acute migraine headache
- Moderate to severe acute pain
Common side effects
- Gastrointestinal bleeding or ulceration
- Renal impairment
- Cardiovascular events (myocardial infarction, stroke)
- Hypersensitivity reactions
- Injection site reactions
Key clinical trials
- Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery (NA)
- The Efface of Lidocaine vs. Magnesium Sulphate in the Management of Pain After Laparoscopic Cholecystectomy (PHASE1)
- The Efface of Ketamine vs. Lidocaine in the Management of Pain After Laparoscopic Cholecystectomy (PHASE1)
- The Efface of Ketamine vs. Magnesium Sulphate in the Management of Pain After Laparoscopic Cholecystectomy (PHASE1)
- Topical Diclofenac for Prevention of Radiation-induced Dermatitis (NA)
- Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair. (NA)
- Diclofenac IM Versus Tramadol IV in Acute Renal Colic, RCT (PHASE4)
- Non-contrast Magnetic Resonance Angiography in Deep Inferior Epigastric Perforator Flap Breast Reconstruction Planning (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:
- IV Diclofenac CI brief — competitive landscape report
- IV Diclofenac updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about IV Diclofenac
What is IV Diclofenac?
How does IV Diclofenac work?
What is IV Diclofenac used for?
Who makes IV Diclofenac?
What drug class is IV Diclofenac in?
What development phase is IV Diclofenac in?
What are the side effects of IV Diclofenac?
What does IV Diclofenac target?
Related
- Drug class: All Nonsteroidal anti-inflammatory drug (NSAID) drugs
- Target: All drugs targeting COX-1, COX-2
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Pain Management, Rheumatology, Gastroenterology
- Indication: Drugs for Acute postoperative pain
- Indication: Drugs for Acute migraine headache
- Indication: Drugs for Moderate to severe acute pain
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing