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SER-401

Microbiome therapy · Immune activation

Phase 1 Most advanced trial (none active)

1 Registered trials

What is SER-401?

SER-401 is a donor-derived microbiome therapeutic composed of selected microbes that restore a healthy gut microbiome signature associated with robust immunotherapy response in melanoma patients. It enhances microbial diversity and function in the gastrointestinal tract to improve immunological activity and response to anti-PD-1 immunotherapy.

Summary written with AI from the sources listed at the end of this page.

At a glance

Drug type: Microbiome therapy
Mechanism: Immune activation
Pathways: immune_activation
Therapy area: Oncology
In trials of: MCRB
FDA status: Investigational, not approved in the US. Most advanced trial: Phase 1

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT03817125	Phase 1	Metastatic Melanoma	Completed	MCRB

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Metastatic Melanoma

Sources

Updated Oct 3, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z