What AcelRx Pharmaceuticals, Inc. does

Talphera (formerly AcelRx Pharmaceuticals, Inc.) is a San Mateo, California-based specialty pharmaceutical company developing drug-device products for medically supervised settings such as intensive care units, dialysis units, and operating rooms. The company's pipeline is built around the broad-spectrum serine protease inhibitor nafamostat mesylate. Its lead candidate, Niyad, is a lyophilized nafamostat formulation designed as a regional anticoagulant for the extracorporeal circuit during continuous renal replacement therapy (CRRT) and intermittent hemodialysis in patients who cannot tolerate heparin; it is regulated by FDA as a device, has received breakthrough device designation, and has a PMA submission filed with top-line data expected by end of 2025. A second nafamostat candidate, LTX-608, is being developed as a pharmaceutical (NDA submitted) for COVID-19, disseminated intravascular coagulation, acute respiratory distress syndrome, and acute pancreatitis.

The company's product portfolio also includes two 10 mL ready-to-use prefilled syringe candidates, Fedsyra (ephedrine hydrochloride) and PFS-02 (phenylephrine hydrochloride), developed in partnership with France-based Laboratoire Aguettant for perioperative and acute care hypotension. Following the 2023 divestiture of its legacy approved asset, the sublingual sufentanil product DSUVIA, to Alora Pharmaceuticals, Talphera's current revenue is limited to a 15% royalty on Alora's commercial net sales of DSUVIA, a 75% royalty on sales to the U.S. Department of Defense, and up to $116.5 million in contingent sales-based milestones. Future revenue depends on FDA approval and commercial launches of Niyad, LTX-608, Fedsyra, and PFS-02, with a planned enterprise field sales motion targeting hospitals and healthcare providers in medically supervised environments. Talphera is led by CEO Vincent J. Angotti with a board chaired by Adrian Adams and engages in ongoing virtual investor and analyst communications through a dedicated IR portal.

Name

AcelRx Pharmaceuticals, Inc.

Legal name

Talphera

Website

https://acelrx.com

Company type

Private

Operating status

Operating

Short description

Talphera (formerly AcelRx Pharmaceuticals) develops drug-device therapies for medically supervised settings, with lead candidate Niyad (nafamostat mesylate) as a regional anticoagulant for renal replacement therapy, plus pipeline assets in perioperative prefilled syringes and inflammatory indications.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Nephrology & Urology Pharmaceuticals (HLAIAAAM)

akta.pro secondary industries

Renal Care Ancillaries (Anemia Management Devices, Phosphate Binder Support, Nutrition Monitoring) (HLAHAKAK), Nephrology & Urology Specialty Pharmaceuticals (HLAIACAH), Gastroenterology & Hepatology Pharmaceuticals (HLAIAAAI)

Keywords

• Specialty pharmaceuticals
• Drug-device combinations
• Regional anticoagulants
• Prefilled syringes
• Renal replacement therapy

Headquarters

HQ city

San Mateo

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Revenue model

1. DSUVIA Royalty Revenue: Following divestment of DSUVIA to Alora Pharmaceuticals in April 2023, Talphera receives a 15% royalty on commercial net sales, a 75% royalty on net sales to the US Department of Defense, and up to $116.5 million in sales-based milestone payments.
2. Niyad (future commercial revenue): Upon FDA approval, Niyad will be commercialized as the first FDA-approved regional anticoagulant for extracorporeal circuits, targeting patients undergoing renal replacement therapy who cannot tolerate heparin.
3. Prefilled Syringes (future commercial revenue): Fedsyra and PFS-02 prefilled syringes will be commercialized pending regulatory approvals, in partnership with Laboratoire Aguettant.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Talphera (formerly AcelRx Pharmaceuticals) develops and commercializes innovative therapies and drug-device products for use in medically supervised care settings. Its lead product candidate Niyad® (nafamostat mesylate) is a regional anticoagulant for extracorporeal circuits during continuous renal replacement therapy (CRRT), regulated as a device by the FDA. The company also develops prefilled syringe candidates Fedsyra™ (ephedrine) and PFS-02 (phenylephrine) for perioperative hypotension, and LTX-608™, a nafamostat formulation for inflammatory and antiviral indications.

Product overview

Talphera (formerly AcelRx Pharmaceuticals) is a pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. The company's product portfolio consists of pipeline candidates and a divested approved product. Lead candidate Niyad® (nafamostat mesylate) is a regional anticoagulant for renal replacement therapy (RRT) regulated as a device. Additional pipeline candidates include LTX-608™ (nafamostat for various inflammatory/anti-viral indications regulated as pharmaceuticals), and two pre-filled syringe candidates Fedsyra™ (ephedrine) and PFS-02 (phenylephrine) developed in partnership with Laboratoire Aguettant. The company previously had DSUVIA, an FDA-approved acute pain product, which was divested to Alora Pharmaceuticals in 2023. The company continues to receive royalty payments from DSUVIA sales.

Differentiator

Problem solved

Functional benefit

Brands

• DSUVIA: FDA-approved acute pain product, divested to Alora Pharmaceuticals in April 2023. Talphera retains 15% royalty on commercial net sales, 75% royalty on DoD net sales, and up to $116.5M in sales-based milestone payments.
• Niyad
• LTX-608
• Fedsyra
• PFS-02

Products and services

• Niyad® Niyad® (nafamostat mesylate) is a lyophilized regional anticoagulant product candidate for injection into the extracorporeal circuit during renal replacement therapy (RRT). It is regulated as a device by the FDA and is positioned to be the first FDA-approved regional anticoagulant for use in the extracorporeal circuit, with an 8-minute half-life enabling rapid clearance from blood.
• LTX-608™ LTX-608 is a nafamostat product candidate regulated as a pharmaceutical for various indications including COVID-19, disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), and acute pancreatitis. It has broad anti-inflammatory and antiviral potential.
• Fedsyra™ Fedsyra is a 10 mL ready-to-use prefilled syringe of ephedrine hydrochloride in development for the treatment of hypotension during general anesthesia. Developed in partnership with Laboratoire Aguettant to streamline care with waste reduction, time savings, improved safety, and lower medication error risk.
• PFS-02 PFS-02 is a 10 mL ready-to-use prefilled syringe of phenylephrine hydrochloride in development for the treatment of hypotension due to vasodilation, as well as for acute pancreatitis and clotting diseases. Developed in partnership with Laboratoire Aguettant.
• DSUVIA DSUVIA was an FDA-approved sublingual sufentanil tablet for acute pain management in medically supervised settings. It was divested to Alora Pharmaceuticals in April 2023, with Talphera retaining a 15% royalty on commercial net sales, 75% royalty on DoD net sales, and up to $116.5 million in sales-based milestone payments.

Quantifiable outcome

• Nafamostat demonstrated significant safety and efficacy improvements over current standards of care according to 2022 meta-analysis.

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• Laboratoire AguettantcoreStrategic or Co-development Partner · 1 January 2023Talphera partnered with the France-based pharmaceutical company Laboratoire Aguettant to develop prefilled syringe product candidates Fedsyra (ephedrine) and PFS-02 (phenylephrine). The partnership leverages Aguettant's expertise in pharmaceutical manufacturing to create ready-to-use injectable medications for perioperative and acute-care settings.

Scale indicators3 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Baxter International: Baxter is a global medical products company with significant CRRT/dialysis solutions (e.g., PrisMax, HDx therapy) and a broad injectable pharma portfolio, overlapping directly with Talphera's Niyad (CRRT anticoagulation) and prefilled syringe strategies.
• Fresenius Medical Care: Fresenius is the largest dialysis products and services provider globally, manufacturing CRRT machines and dialyzers. It is the most natural incumbent peer for Niyad given its dominant share of the U.S. dialysis patient population that would be treated with Niyad.
• Hikma Pharmaceuticals: Hikma is a multinational specialty pharmaceutical company with a strong hospital injectables business, including prefilled syringes. It is comparable to Talphera in targeting the same perioperative and acute care hospital channel with injectable presentations.
• Becton, Dickinson and Company (BD): BD is a global leader in prefilled syringes, injection systems, and drug delivery devices, competing with Talphera's Fedsyra and PFS-02 prefilled syringe products in the perioperative and acute care hospital channel.

Direct peers

• B. Braun Melsungen: B. Braun is a leading manufacturer of prefilled syringes (e.g., ephedrine, phenylephrine ready-to-use injectables) and renal care products, directly comparable to Talphera's Fedsyra/PFS-02 portfolio and the renal care positioning of Niyad.
• ICU Medical: ICU Medical specializes in IV infusion therapy, critical care, and dialysis connection/disposables, making it a direct peer in the hospital-based infusion and renal care channels that Talphera's products are designed to serve.

Emerging players

• Outset Medical: Outset Medical produces the Tablo hemodialysis system used in hospitals and at home. As a CRRT/IHD-adjacent company, it shares the renal replacement therapy customer base that Niyad would address.
• Amphastar Pharmaceuticals: Amphastar is a specialty injectable pharmaceutical company that develops and markets injectable generic and proprietary products, including hospital-based injectables. It is comparable to Talphera's injectable pharmaceutical pipeline and the prefilled syringe strategy.
• ANI Pharmaceuticals: ANI Pharmaceuticals is a specialty generics and branded pharmaceutical company with a portfolio in critical care and hospital injectables, with a comparable small-cap specialty pharma profile to Talphera.
• Eagle Pharmaceuticals: Eagle Pharmaceuticals is a specialty pharma focused on hospital-based injectables and ready-to-use formulations, with overlapping strategy around ready-to-use syringe presentations in critical care settings similar to Fedsyra and PFS-02.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/acelrx-pharmaceuticals-inc-

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about AcelRx Pharmaceuticals, Inc.