Surotomycin

Summary

Surotomycin (CB-315) is a cyclic lipodepsipeptide antibiotic structurally related to daptomycin, developed for the treatment of Clostridioides difficile infection (CDI). It acts locally in the gut with minimal systemic absorption. Phase III clinical trials showed non-inferiority to vancomycin for clinical cure but failed to demonstrate superiority in sustained clinical response, leading to discontinuation of further development by Merck.

Mechanism of Action

Binds to bacterial membranes in a calcium-dependent manner, causing membrane depolarization and disruption of cell membrane integrity, leading to cell death; active against Clostridioides difficile with minimal systemic absorption

Routes of Administration

Goals & Uses

• Prevention of CDI recurrenceAnti InfectiveModerate
• Treatment of Clostridioides difficile infectionAntimicrobialModerate

Contraindications

• Hypersensitivity to surotomycin or related lipodepsipeptidesAllergyHigh

Adverse Effects

• HeadacheNeurologicUncommonPain in the head or upper neck
• NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
• VomitingGastrointestinalCommonForceful expulsion of stomach contents
• DiarrheaGastrointestinalCommonLoose or frequent stools
• Abdominal painGastrointestinalCommonPain or discomfort in the abdomen

Drug Interactions

• HMG-CoA reductase inhibitors (statins)Low

Population Constraints

• Severe renal impairmentOrgan ImpairmentRelative
• Pediatric patientsAgeRelative
• Pregnant womenReproductiveRelative

Regulatory Status

• European UnionInvestigationalNo marketing authorization application filed; development discontinued
• United StatesInvestigationalPhase III trials completed; program discontinued by Merck around 2016-2017; no NDA filed
• United KingdomInvestigationalNo regulatory submission; development discontinued globally

Surotomycin did not receive regulatory approval in any jurisdiction. Phase III trials (ACACIA trials) completed but did not meet primary endpoints for superiority over vancomycin; program was discontinued around 2016-2017.

Evidence & Sources

No sources recorded yet.