Last reviewed · How we verify
artesunate-pyronaridine
artesunate-pyronaridine is a Small molecule drug developed by Centre de Recherche Médicale de Lambaréné. It is currently in Phase 2 development. Also known as: Pyramax.
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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 | artesunate-pyronaridine |
|---|---|
| Also known as | Pyramax |
| Sponsor | Centre de Recherche Médicale de Lambaréné |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Tafenoquine and ACTs (TADORE- Plus) (PHASE4)
- A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults (PHASE1)
- Health Systems Implementation and Molecular Surveillance of Multiple First-Line Treatments for Uncomplicated Malaria in Western Kenya
- Safety of Antimalarials in the FIRst trimEster (PHASE3)
- In Vivo Efficacy of Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate in Mozambique (PHASE4)
- Four Different Experimental Drug Regimens to Standard of Care for the Treatment of Symptomatic Outpatients With COVID-19 (PHASE2)
- Comparing Safety and Protective Efficacy of Vaccine Candidate PfSPZ-CVac and MVA ME-TRAP/ ChAd63 ME-TRAP in Adults (PHASE1, PHASE2)
- Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso (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:
- artesunate-pyronaridine CI brief — competitive landscape report
- artesunate-pyronaridine updates RSS · CI watch RSS
- Centre de Recherche Médicale de Lambaréné portfolio CI
Frequently asked questions about artesunate-pyronaridine
What is artesunate-pyronaridine?
Who makes artesunate-pyronaridine?
Is artesunate-pyronaridine also known as anything else?
What development phase is artesunate-pyronaridine in?
Related
- Manufacturer: Centre de Recherche Médicale de Lambaréné — full pipeline
- Also known as: Pyramax
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing