Artesunate vaginal insert

Frantz Viral Therapeutics, LLC · Phase 2 active Small molecule

Artesunate vaginal insert is a Antimalarial Small molecule drug developed by Frantz Viral Therapeutics, LLC. It is currently in Phase 2 development for Malaria. Also known as: Artesunic acid, DHA, artemisinin.

Artesunate is a derivative of artemisinin that targets the heme moiety of the malaria parasite, disrupting its 80-kDa protein.

Artesunate is a derivative of artemisinin that targets the heme moiety of the malaria parasite, disrupting its 80-kDa protein. Used for Malaria.

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	Artesunate vaginal insert
Also known as	Artesunic acid, DHA, artemisinin
Sponsor	Frantz Viral Therapeutics, LLC
Drug class	Antimalarial
Target	Heme moiety of the malaria parasite
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Artesunate is a potent antimalarial agent that works by inhibiting the parasite's heme detoxification system, ultimately leading to its death.

Approved indications

• Malaria

Common side effects

• Nausea
• Vomiting
• Diarrhea

Key clinical trials

• Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya (PHASE2)
• Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3) (PHASE2)
• Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya (PHASE1)
• Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya (PHASE1)

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 vaginal insert CI brief — competitive landscape report
• Artesunate vaginal insert updates RSS · CI watch RSS
• Frantz Viral Therapeutics, LLC portfolio CI

Frequently asked questions about Artesunate vaginal insert

What is Artesunate vaginal insert?

Artesunate vaginal insert is a Antimalarial drug developed by Frantz Viral Therapeutics, LLC, indicated for Malaria.

How does Artesunate vaginal insert work?

Artesunate is a derivative of artemisinin that targets the heme moiety of the malaria parasite, disrupting its 80-kDa protein.

What is Artesunate vaginal insert used for?

Artesunate vaginal insert is indicated for Malaria.

Who makes Artesunate vaginal insert?

Artesunate vaginal insert is developed by Frantz Viral Therapeutics, LLC (see full Frantz Viral Therapeutics, LLC pipeline at /company/frantz-viral-therapeutics-llc).

Is Artesunate vaginal insert also known as anything else?

Artesunate vaginal insert is also known as Artesunic acid, DHA, artemisinin.

What drug class is Artesunate vaginal insert in?

Artesunate vaginal insert belongs to the Antimalarial class. See all Antimalarial drugs at /class/antimalarial.

What development phase is Artesunate vaginal insert in?

Artesunate vaginal insert is in Phase 2.

What are the side effects of Artesunate vaginal insert?

Common side effects of Artesunate vaginal insert include Nausea, Vomiting, Diarrhea.

What does Artesunate vaginal insert target?

Artesunate vaginal insert targets Heme moiety of the malaria parasite and is a Antimalarial.

Related

• Drug class: All Antimalarial drugs
• Target: All drugs targeting Heme moiety of the malaria parasite
• Manufacturer: Frantz Viral Therapeutics, LLC — full pipeline
• Therapeutic area: All drugs in Infectious Disease
• Indication: Drugs for Malaria
• Also known as: Artesunic acid, DHA, artemisinin