Products

AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. For more information, please select a product below.

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

NAFAMOSTAT MESYLATE PRODUCTS
 

Niyad™

Nafamostat mesylate in development as a regional anticoagulant for injection into the extracorporeal circuit. *Final formulation qualification needed prior to Phase 3 initiation.

LTX-608

IV nafamostat mesylate in development for multiple conditions, including an anti-viral treatment for COVID-19, disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), and acute pancreatitis.


PRE-FILLED SYRINGE PRODUCTS
 

Fedsrya™

Ephedrine as a 10mL ready to use pre-filled syringe of 3mg/mL ephedrine hydrochloride in development for treatment of hypotension during general anesthesia.

PFS-02

Phenylephrine as a 10mL ready to use pre-filled syringe of 50mg/mL phenylephrine hydrochloride in development for treatment of hypotension due to vasodilation (e.g. spinal anesthesia).


SUFENTANIL SUBLINGUAL PRODUCTS
 

DSUVIA (sufentanil) sublingual tablet 30 mcg

In November of 2018, DSUVIA was approved by the U.S. Food and Drug Administration.

To learn more about DSUVIA, please visit DSUVIA.com.

In June of 2018, AcelRx received approval for DZUVEO from the European Commission for use in medically monitored settings.

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.

 

AcelRx Pharmaceuticals makes no claims of safety or effectiveness about unapproved products. Unapproved products are not available for commercial use anywhere. Investigational products are limited by law to investigational use only.