Last reviewed 2026-04-22 · How we verify

Artemether Sublingual Spray

Proto Pharma Ltd · Phase 3 active Small molecule

Artemether Sublingual Spray is a Artemisinin derivative Small molecule drug developed by Proto Pharma Ltd. It is currently in Phase 3 development for Malaria (Plasmodium falciparum and other species). Also known as: ArTiMist.

Artemether is an artemisinin derivative that kills malaria parasites by generating reactive oxygen species that damage parasite proteins and membranes.

Artemether is an artemisinin derivative that kills malaria parasites by generating reactive oxygen species that damage parasite proteins and membranes. Used for Malaria (Plasmodium falciparum and other species).

Likelihood of approval

60.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).
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	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	Artemether Sublingual Spray
Also known as	ArTiMist
Sponsor	Proto Pharma Ltd
Drug class	Artemisinin derivative
Target	Heme iron (parasite-derived); multiple parasite proteins and membranes
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 3

Mechanism of action

Artemether, a semi-synthetic derivative of artemisinin from Artemisia annua, acts as a fast-acting antimalarial agent. Upon activation by heme iron in Plasmodium parasites, it generates highly reactive oxygen species that cause oxidative damage to parasite proteins, lipids, and DNA. The sublingual spray formulation is designed to provide rapid systemic absorption for quick therapeutic effect.

Approved indications

Malaria (Plasmodium falciparum and other species)

Common side effects

Nausea
Vomiting
Dizziness
Headache
Abdominal pain

Key clinical trials

A Phase 1/2a Study of LON002 in Subjects With Advanced Solid Tumours (PHASE1, PHASE2)
Superiority of ArTiMist Versus Quinine in Children With Severe Malaria (PHASE3)
Efficacy of ArTiMist™ in Children (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:

Artemether Sublingual Spray CI brief — competitive landscape report
Artemether Sublingual Spray updates RSS · CI watch RSS
Proto Pharma Ltd portfolio CI

Frequently asked questions about Artemether Sublingual Spray

What is Artemether Sublingual Spray?

Artemether Sublingual Spray is a Artemisinin derivative drug developed by Proto Pharma Ltd, indicated for Malaria (Plasmodium falciparum and other species).

How does Artemether Sublingual Spray work?

Artemether is an artemisinin derivative that kills malaria parasites by generating reactive oxygen species that damage parasite proteins and membranes.

What is Artemether Sublingual Spray used for?

Artemether Sublingual Spray is indicated for Malaria (Plasmodium falciparum and other species).

Who makes Artemether Sublingual Spray?

Artemether Sublingual Spray is developed by Proto Pharma Ltd (see full Proto Pharma Ltd pipeline at /company/proto-pharma-ltd).

Is Artemether Sublingual Spray also known as anything else?

Artemether Sublingual Spray is also known as ArTiMist.

What drug class is Artemether Sublingual Spray in?

Artemether Sublingual Spray belongs to the Artemisinin derivative class. See all Artemisinin derivative drugs at /class/artemisinin-derivative.

What development phase is Artemether Sublingual Spray in?

Artemether Sublingual Spray is in Phase 3.

What are the side effects of Artemether Sublingual Spray?

Common side effects of Artemether Sublingual Spray include Nausea, Vomiting, Dizziness, Headache, Abdominal pain.

What does Artemether Sublingual Spray target?

Artemether Sublingual Spray targets Heme iron (parasite-derived); multiple parasite proteins and membranes and is a Artemisinin derivative.

Drug class: All Artemisinin derivative drugs
Target: All drugs targeting Heme iron (parasite-derived); multiple parasite proteins and membranes
Manufacturer: Proto Pharma Ltd — full pipeline
Therapeutic area: All drugs in Infectious Disease
Indication: Drugs for Malaria (Plasmodium falciparum and other species)
Also known as: ArTiMist

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