About AcelRx

AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's lead product candidate, Niyad is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. AcelRx is also developing two pre-filled syringes in-licensed from its partner Aguettant: Fedsyra™, a pre-filled ephedrine syringe, with an expected NDA filing in the first half of 2023, and PFS-02, a pre-filled phenylephrine syringe with an expected NDA filing in 2024.

Portfolio Overview

Nafamostat product candidates

Niyad™

Anticoagulation of the extracorporeal circuit–CRRT/IHD regulated as device

Expected EUA submission in 2023; registrational study expected to be initiated in H2 2023

 
  • Pre-Clinical
  • Phase 1
  • Phase 2
  • Phase 3
  • NDA Submitted
  • Approved
LTX-608™

Various indications regulated as drugs *

 
  • Pre-Clinical
  • Phase 1
  • Phase 2
  • Phase 3
  • NDA Submitted
  • Approved

Pre-filled syringe product candidates

Fedsyra™

Ephedrine 10 ml ready to use pre-filled syringe of 3 mg/ml ephedrine hydrochloride

NDA submission expected in 2023

 
  • Pre-Clinical
  • Phase 1
  • Phase 2
  • Phase 3
  • NDA Submitted
  • Approved
PFS-02

Phenylephrine 10 ml ready to use pre-filled syringe of 50 mcg/ml phenylephrine hydrochloride

NDA submission expected in 2024

 
  • Pre-Clinical
  • Phase 1
  • Phase 2
  • Phase 3
  • NDA Submitted
  • Approved

DSUVIA®

DSUVIA®

DSUVIA was divested to Alora Pharmaceuticals in April 2023. AcelRx will receive a 15% royalty on commercial net sales, 75% royalty on net sales to the Department of Defense, and up to $116.5 million in milestone payments.