Last reviewed 2026-04-20 · How we verify

Arteether (ARTEMOTIL)

Phase 2 active Small molecule

Arteether (generic name: ARTEMOTIL) is a artemotil drug. It is currently in Phase 2 development.

Arteether works by targeting and disrupting the cell membrane of malaria parasites, ultimately leading to their death.

Arteether, also known as artemotil, is a small molecule drug in the artemotil class. It is a derivative of artemisinin, a compound extracted from the Artemisia annua plant. Arteether is used to treat malaria, a disease caused by Plasmodium parasites. The commercial status of arteether is unclear, and it is not FDA-approved. Further research is needed to determine its safety and efficacy.

Likelihood of approval

17.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	ARTEMOTIL
Drug class	artemotil
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine a strong detergent that breaks down the protective layer around a cell. Arteether is like that detergent, but for malaria parasites. It gets inside the parasite's cell and breaks down its membrane, causing the parasite to die.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer (NeoART-V) (PHASE2)

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:

Arteether CI brief — competitive landscape report
Arteether updates RSS · CI watch RSS

Frequently asked questions about Arteether

What is Arteether?

Arteether (ARTEMOTIL) is a artemotil drug.

How does Arteether work?

Arteether works by targeting and disrupting the cell membrane of malaria parasites, ultimately leading to their death.

What is the generic name of Arteether?

ARTEMOTIL is the generic (nonproprietary) name of Arteether.

What drug class is Arteether in?

Arteether belongs to the artemotil class. See all artemotil drugs at /class/artemotil.

What development phase is Arteether in?

Arteether is in Phase 2.

Drug class: All artemotil drugs
Therapeutic area: All drugs in Infectious Disease

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing