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Novel Ibuprofen
Novel Ibuprofen is a Nonsteroidal anti-inflammatory drug (NSAID) Small molecule drug developed by Pfizer. It is currently in Phase 3 development for Pain and inflammation (acute or chronic), Fever reduction.
Novel Ibuprofen inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and decrease inflammation, pain, and fever.
Novel Ibuprofen inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and decrease inflammation, pain, and fever. Used for Pain and inflammation (acute or chronic), Fever reduction.
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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 | Novel Ibuprofen |
|---|---|
| Sponsor | Pfizer |
| Drug class | Nonsteroidal anti-inflammatory drug (NSAID) |
| Target | COX-1 and COX-2 |
| Modality | Small molecule |
| Therapeutic area | Pain Management / Inflammation |
| Phase | Phase 3 |
Mechanism of action
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that works by inhibiting both COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins—key mediators of inflammation, pain, and fever. By reducing prostaglandin levels, the drug provides analgesic, anti-inflammatory, and antipyretic effects. The 'novel' formulation likely refers to an improved delivery system, dosing regimen, or safety profile compared to conventional ibuprofen.
Approved indications
- Pain and inflammation (acute or chronic)
- Fever reduction
Common side effects
- Gastrointestinal upset (nausea, dyspepsia, abdominal pain)
- Headache
- Dizziness
- Rash
- Gastrointestinal bleeding (with chronic use)
Key clinical trials
- Immediate Restoration of a New Implant With High Primary Stability (NA)
- Musculoskeletal Outcomes Using Tylenol/Ibuprofen vs. Oral Steroids in New Injuries (PHASE4)
- Adherence and Perspiration While Wearing Lower Limb Prostheses (NA)
- The Effectiveness of Quadro İliac Plane Block in Percutaneous Nephrolithotomies (NA)
- Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) (PHASE1, PHASE2)
- Radiofrequency Ablation: Treatment for Posterior Element Pain From Vertebral Compression Fractures (PHASE4)
- Retrospective Evaluation of Efficacy of Meta-PENG Block
- Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot (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:
- Novel Ibuprofen CI brief — competitive landscape report
- Novel Ibuprofen updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about Novel Ibuprofen
What is Novel Ibuprofen?
How does Novel Ibuprofen work?
What is Novel Ibuprofen used for?
Who makes Novel Ibuprofen?
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What development phase is Novel Ibuprofen in?
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What does Novel Ibuprofen target?
Related
- Drug class: All Nonsteroidal anti-inflammatory drug (NSAID) drugs
- Target: All drugs targeting COX-1 and COX-2
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Pain Management / Inflammation
- Indication: Drugs for Pain and inflammation (acute or chronic)
- Indication: Drugs for Fever reduction
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing