Last reviewed 2026-05-31 · How we verify

MMV390048 formulation B

Medicines for Malaria Venture · Phase 1 active Small molecule ✓ Verified May 2026

MMV390048 formulation B is a Small molecule drug developed by Medicines for Malaria Venture. It is currently in Phase 1 development.

MMV390048 formulation B is an oral medication being studied for the treatment of malaria. It is part of a Phase 1 exploratory study to evaluate its pharmacokinetics in healthy volunteers.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	MMV390048 formulation B
Sponsor	Medicines for Malaria Venture
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Evaluate the Pharmacokinetics of Oral Formulations of MMV390048 Administered Fasted to Healthy Volunteers (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:

MMV390048 formulation B CI brief — competitive landscape report
MMV390048 formulation B updates RSS · CI watch RSS
Medicines for Malaria Venture portfolio CI

Frequently asked questions about MMV390048 formulation B

What is MMV390048 formulation B?

MMV390048 formulation B is a Small molecule drug developed by Medicines for Malaria Venture.

Who makes MMV390048 formulation B?

MMV390048 formulation B is developed by Medicines for Malaria Venture (see full Medicines for Malaria Venture pipeline at /company/medicines-for-malaria-venture).

What development phase is MMV390048 formulation B in?

MMV390048 formulation B is in Phase 1.

Manufacturer: Medicines for Malaria Venture — full pipeline

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