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Proparacetamol (PROPACETAMOL)
Proparacetamol (generic name: PROPACETAMOL) is a propacetamol drug. It is currently in Phase 2 development.
Propacetamol works by inhibiting the synthesis of prostaglandins, which are involved in pain and fever pathways.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | PROPACETAMOL |
|---|---|
| Drug class | propacetamol |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | Phase 2 |
Mechanism of action
Imagine your body has a thermostat that controls how much pain and inflammation you feel. Propacetamol helps turn down this thermostat by blocking the production of certain chemicals called prostaglandins, which are involved in sending pain signals to your brain.
Approved indications
Common side effects
- Febrile neutropenia
Key clinical trials
- Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain (NA)
- Comparison of the Effect of Propacetamol, Ibuprofen or Their Combination on Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children (NA)
- Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy (NA)
- The Effect of Additional Propacetamol Infusion on Post Procedural Outcome and Opioid Consumption During Catheter Ablation of Atrial Fibrillation. (NA)
- Effects of Postoperative Pain Management on Immune Function After Laparoscopic Resection of Colorectal Cancer (NA)
- Dexamethasone Versus Local Infiltration Technique for Tonsillectomy in Children (NA)
- The Opioid-sparing Effect and Reduced PONV Using Propacetamol in PCA Among Patients With High Risk of PONV (NA)
- A Comparison of Nefopam-propacetamol Combination and Propacetamol for Postoperative Quality of Recovery After Laparoscopic Nephrectomy (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:
- Proparacetamol CI brief — competitive landscape report
- Proparacetamol updates RSS · CI watch RSS
Frequently asked questions about Proparacetamol
What is Proparacetamol?
How does Proparacetamol work?
What is the generic name of Proparacetamol?
What drug class is Proparacetamol in?
What development phase is Proparacetamol in?
What are the side effects of Proparacetamol?
Related
- Drug class: All propacetamol drugs
- Therapeutic area: All drugs in Pain
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing