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Eurartesim
Eurartesim is a Small molecule drug developed by sigma-tau i.f.r. S.p.A.. It is currently in Phase 1 development. Also known as: Dihydroartemisinin and Piperaquine combination therapy.
Eurartesim is a fixed dose combination medication used to treat malaria, specifically for P. falciparum and P. vivax types. It is a small molecule medication that combines dihydroartemisinin and piperaquine, which is taken by mouth.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Eurartesim |
|---|---|
| Also known as | Dihydroartemisinin and Piperaquine combination therapy |
| Sponsor | sigma-tau i.f.r. S.p.A. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Investigating the Pharmacology of Tafenoquine in Papua New Guinean Children With Uncomplicated Malaria (PHASE4)
- Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi (PHASE4)
- IGHID 12334 - After the Flood: Optimal Strategies to Prevent Malaria Epidemics Caused by Severe Flooding (NA)
- Dihydroartemisinin-Piperaquine in the Context of Antiretroviral Therapy (PHASE4)
- The Transmission of Artemisinin Resistant Parasites Before and After Conventional Artemisinin-combination Therapy (PHASE4)
- Comparing Chemoprevention Drugs for School-based Malaria Control (PHASE4)
- DHA-PQP vs Chloroquine and Primaquine for Radical Cure of Vivax Malaria in Brazil (PHASE3)
- Comparing Chemoprevention Approaches for School-based Malaria Control (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:
- Eurartesim CI brief — competitive landscape report
- Eurartesim updates RSS · CI watch RSS
- sigma-tau i.f.r. S.p.A. portfolio CI
Frequently asked questions about Eurartesim
What is Eurartesim?
Who makes Eurartesim?
Is Eurartesim also known as anything else?
What development phase is Eurartesim in?
Related
- Manufacturer: sigma-tau i.f.r. S.p.A. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Dihydroartemisinin and Piperaquine combination therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing