A Phase 3 Prospective, Randomized, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of BV100 Plus Low-dose Polymyxin B Compared With Colistin Plus High-dose Ampicillin/Sulbactam in the Treatment of Adult Patients With Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Caused by Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
Latest Information Update: 23 Sep 2026
At a glance
- Drugs Polymixin B (Primary) ; Polymixin B (Primary) ; Rifabutin (Primary) ; Ampicillin/sulbactam; Colistin; Meropenem
- Indications Acinetobacter infections; Nosocomial pneumonia; Ventilator associated pneumonia
- Focus Registrational; Therapeutic Use
- Acronyms BV100 RIV-TARGET; RIV-TARGET
- Sponsors BioVersys
Most Recent Events
- 09 Sep 2026 According to a BioVersys media release, The first Data Safety Monitoring Board (DSMB) review is anticipated by the end of 2026. Guidance remains for last patient enrolled for end of 2027, and first submissions for regulatory approval anticipated by mid-2028. Topline data read-out from RIV-TARGET is anticipated for early 2028.
- 04 May 2026 Planned primary completion date changed from 1 Dec 2027 to 30 Dec 2027.
- 16 Apr 2026 According to a BioVersys media release, the company announced the first patient first visit in this trial. This global pivotal Phase 3 trial is on track to enroll last patient by the end of 2027 and will support first regulatory approval submissions in 2028. The trial will enroll across ~100 sites in ~15 countries.