Last reviewed 2026-05-31 · How we verify

DSM265 ymg

Medicines for Malaria Venture · Phase 2 active Small molecule ✓ Verified May 2026 Quality 45/100

DSM265 ymg is a Antimalarial agent Small molecule drug developed by Medicines for Malaria Venture. It is currently in Phase 2 development.

DSM265 inhibits Plasmodium dihydroorotate dehydrogenase (DHODH), blocking pyrimidine synthesis essential for parasite replication.

DSM265 is a small molecule inhibitor of dihydroorotate dehydrogenase, a target involved in the synthesis of pyrimidine nucleotides essential for the growth and replication of Plasmodium parasites. It has been investigated in clinical trials for the treatment of Plasmodium falciparum and Plasmodium vivax malaria.

Likelihood of approval

15.3% 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).

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	DSM265 ymg
Sponsor	Medicines for Malaria Venture
Drug class	Antimalarial agent
Modality	Small molecule
Phase	Phase 2

Mechanism of action

DSM265 selectively inhibits the parasite enzyme DHODH, which is critical for de novo pyrimidine biosynthesis in Plasmodium species. By blocking this pathway, the drug prevents parasite DNA replication and growth. The compound shows selectivity for the parasite enzyme over human DHODH.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

DSM265 Phase IIa Investigation Treating Plasmodium Falciparum or Vivax (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:

DSM265 ymg CI brief — competitive landscape report
DSM265 ymg updates RSS · CI watch RSS
Medicines for Malaria Venture portfolio CI

Frequently asked questions about DSM265 ymg

What is DSM265 ymg?

DSM265 ymg is a Antimalarial agent drug developed by Medicines for Malaria Venture.

How does DSM265 ymg work?

DSM265 inhibits Plasmodium dihydroorotate dehydrogenase (DHODH), blocking pyrimidine synthesis essential for parasite replication.

Who makes DSM265 ymg?

DSM265 ymg is developed by Medicines for Malaria Venture (see full Medicines for Malaria Venture pipeline at /company/medicines-for-malaria-venture).

What drug class is DSM265 ymg in?

DSM265 ymg belongs to the Antimalarial agent class. See all Antimalarial agent drugs at /class/antimalarial-agent.

What development phase is DSM265 ymg in?

DSM265 ymg is in Phase 2.

Drug class: All Antimalarial agent drugs
Manufacturer: Medicines for Malaria Venture — full pipeline

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