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paracetamol-NSAID
paracetamol-NSAID is a Analgesic combination (paracetamol + NSAID) Small molecule drug developed by University of Monastir. It is currently in Phase 3 development for Acute pain management, Fever reduction. Also known as: combination.
This combination drug pairs paracetamol's direct analgesic and antipyretic effects with NSAID anti-inflammatory activity to provide enhanced pain relief and fever reduction.
This combination drug pairs paracetamol's direct analgesic and antipyretic effects with NSAID anti-inflammatory activity to provide enhanced pain relief and fever reduction. Used for Acute pain management, 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).
| 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 | paracetamol-NSAID |
|---|---|
| Also known as | combination |
| Sponsor | University of Monastir |
| Drug class | Analgesic combination (paracetamol + NSAID) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Paracetamol works primarily through central nervous system pathways to reduce pain perception and lower fever set-point, while NSAIDs inhibit cyclooxygenase (COX) enzymes to reduce peripheral prostaglandin production and inflammation. The combination aims to provide synergistic analgesic and anti-inflammatory effects for improved efficacy over either agent alone.
Approved indications
- Acute pain management
- Fever reduction
Common side effects
- Gastrointestinal upset
- Hepatotoxicity (paracetamol-related)
- NSAID-related GI bleeding
- Renal impairment
Key clinical trials
- Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older
- FRONT Block for Quality of Recovery After Total Hip Arthroplasty (NA)
- Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial (PHASE4)
- Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen (PHASE3)
- Helping Osteoarthritis Patients to Walk With NSAID (PHASE4)
- Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients (PHASE4)
- Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis (PHASE3)
- Evaluating Suzetrigine for Pain Control Following TKA (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:
- paracetamol-NSAID CI brief — competitive landscape report
- paracetamol-NSAID updates RSS · CI watch RSS
- University of Monastir portfolio CI
Frequently asked questions about paracetamol-NSAID
What is paracetamol-NSAID?
How does paracetamol-NSAID work?
What is paracetamol-NSAID used for?
Who makes paracetamol-NSAID?
Is paracetamol-NSAID also known as anything else?
What drug class is paracetamol-NSAID in?
What development phase is paracetamol-NSAID in?
What are the side effects of paracetamol-NSAID?
Related
- Drug class: All Analgesic combination (paracetamol + NSAID) drugs
- Manufacturer: University of Monastir — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Acute pain management
- Indication: Drugs for Fever reduction
- Also known as: combination
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing