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Paracetamol caféine
Paracetamol caféine is a Analgesic/antipyretic combination Small molecule drug developed by University of Monastir. It is currently in Phase 3 development for Mild to moderate pain relief, Fever reduction. Also known as: 500mg/ 65mg.
Paracetamol reduces pain and fever by inhibiting prostaglandin synthesis in the central nervous system, while caffeine enhances analgesic efficacy and increases alertness.
Paracetamol reduces pain and fever by inhibiting prostaglandin synthesis in the central nervous system, while caffeine enhances analgesic efficacy and increases alertness. Used for Mild to moderate pain relief, 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 caféine |
|---|---|
| Also known as | 500mg/ 65mg |
| Sponsor | University of Monastir |
| Drug class | Analgesic/antipyretic combination |
| Target | Cyclooxygenase (COX), adenosine receptors |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Paracetamol (acetaminophen) works primarily through inhibition of cyclooxygenase enzymes in the brain and spinal cord, reducing prostaglandin production and thereby lowering pain perception and body temperature set point. Caffeine acts as a central nervous system stimulant and potentiates the analgesic effects of paracetamol, allowing for lower doses and faster onset of action. The combination is commonly used to improve efficacy in pain management.
Approved indications
- Mild to moderate pain relief
- Fever reduction
Common side effects
- Nausea
- Dizziness
- Jitteriness or nervousness (caffeine-related)
- Hepatotoxicity (at high doses)
Key clinical trials
- Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
- Assessment of Oral Caffeine Intake in Changing the Severity of Acute Migraine Attack Using VAS Score Among Patients Attending Headache and Neurology Outpatients Clinic of Ainshams University Hospitals (PHASE4)
- A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo (PHASE3)
- Nebulized Dexmedetomidine or Lidocaine for Treatment of Post Dural Puncture Headache in Parturients Undergoing Elective Cesarean Section Under Spinal Anesthesia (EARLY_PHASE1)
- Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic (PHASE2)
- Awake Caudal Catheter vs General Anesthesia (PHASE4)
- Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine (PHASE4)
- Management of Post Dural Pucture Headache After Lower Limb Surgeries: Oral Prednisolone vs Oral Pregabalin (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:
- Paracetamol caféine CI brief — competitive landscape report
- Paracetamol caféine updates RSS · CI watch RSS
- University of Monastir portfolio CI
Frequently asked questions about Paracetamol caféine
What is Paracetamol caféine?
How does Paracetamol caféine work?
What is Paracetamol caféine used for?
Who makes Paracetamol caféine?
Is Paracetamol caféine also known as anything else?
What drug class is Paracetamol caféine in?
What development phase is Paracetamol caféine in?
What are the side effects of Paracetamol caféine?
What does Paracetamol caféine target?
Related
- Drug class: All Analgesic/antipyretic combination drugs
- Target: All drugs targeting Cyclooxygenase (COX), adenosine receptors
- Manufacturer: University of Monastir — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Mild to moderate pain relief
- Indication: Drugs for Fever reduction
- Also known as: 500mg/ 65mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing