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acetaminophen plus ibuprofen
acetaminophen plus ibuprofen is a NSAID Small molecule drug developed by Nova Scotia Health Authority. It is currently in Phase 3 development for Relief of mild to moderate pain, Reduction of fever.
Acetaminophen works by inhibiting the production of prostaglandins, which are chemicals that cause pain and fever, while ibuprofen works by inhibiting the enzyme COX-2, which is involved in the production of prostaglandins.
Acetaminophen and ibuprofen are small molecule medications used to treat various conditions, including pain, arthritis, and adolescent idiopathic scoliosis. They are often used in combination as part of opioid-free or opioid-containing postoperative pain management pathways.
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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 | acetaminophen plus ibuprofen |
|---|---|
| Sponsor | Nova Scotia Health Authority |
| Drug class | NSAID |
| Target | COX-2 |
| Modality | Small molecule |
| Therapeutic area | Pain management |
| Phase | Phase 3 |
Mechanism of action
Acetaminophen is a non-selective inhibitor of cyclooxygenase enzymes, which are responsible for the production of prostaglandins. Ibuprofen, on the other hand, is a selective inhibitor of COX-2, which is involved in the production of prostaglandins in the body. By inhibiting these enzymes, both drugs are able to reduce the production of prostaglandins, which in turn reduces pain and inflammation.
Approved indications
- Relief of mild to moderate pain
- Reduction of fever
Common side effects
- Gastrointestinal upset
- Rash
- Dizziness
Key clinical trials
- Jaw Muscle Pain Post Wisdom Molar Surgery (PHASE2)
- Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis (NA)
- Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain (NA)
- Helping Osteoarthritis Patients to Walk With NSAID (PHASE4)
- Fentanyl Versus Opioid Free Multimodal Analgesia for Perioperative Pain Control in Children With Mild to Moderate Obstructive Sleep Apnea (NA)
- Musculoskeletal Outcomes Using Tylenol/Ibuprofen vs. Oral Steroids in New Injuries (PHASE4)
- Post-operative Pain Management in Children With Supracondylar Humerus Fractures (PHASE4)
- Opioid-Free Pain Protocol After Shoulder Arthroplasty (PHASE4)
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:
- acetaminophen plus ibuprofen CI brief — competitive landscape report
- acetaminophen plus ibuprofen updates RSS · CI watch RSS
- Nova Scotia Health Authority portfolio CI
Frequently asked questions about acetaminophen plus ibuprofen
What is acetaminophen plus ibuprofen?
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What drug class is acetaminophen plus ibuprofen in?
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Related
- Drug class: All NSAID drugs
- Target: All drugs targeting COX-2
- Manufacturer: Nova Scotia Health Authority — full pipeline
- Therapeutic area: All drugs in Pain management
- Indication: Drugs for Relief of mild to moderate pain
- Indication: Drugs for Reduction of fever
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing