What Talphera does

Talphera is a specialty pharmaceutical company that develops and commercializes therapies for medically supervised settings, primarily hospital intensive care units and perioperative environments. Originally founded in 2005 as AcelRx Pharmaceuticals and renamed Talphera in 2023 following the divestiture of its acute pain product DSUVIA, the company has refocused on regional anticoagulation and injectable drug delivery for critically ill patients.

The company's lead product candidate is Niyad (nafamostat mesylate), a lyophilized formulation of a broad-spectrum serine protease inhibitor positioned to be the first FDA-approved regional anticoagulant for the extracorporeal circuit during continuous renal replacement therapy (CRRT) and intermittent hemodialysis. Niyad has received FDA Breakthrough Device Designation and is in a registrational study (NEPHRO CRRT) enrolling 70 patients across up to 14 U.S. hospital ICUs, with PMA submission planned for 2026. Nafamostat's 8-minute half-life enables rapid clearance and predominantly extracorporeal activity, addressing bleeding-risk patients who cannot tolerate heparin. Additional candidates include LTX-608 (a nafamostat product for inflammatory and antiviral indications including COVID-19, DIC, ARDS, and acute pancreatitis) and two pre-filled syringe products (Fedsyra for ephedrine and PFS-02 for phenylephrine) developed in partnership with Laboratoire Aguettant.

Talphera generates revenue primarily through a 15% royalty on commercial net sales of DSUVIA following its 2023 divestiture to Alora Pharmaceuticals (75% on U.S. Department of Defense sales, plus up to $116.5 million in sales-based milestones). The company is pre-commercial on its own pipeline and funds operations through equity financings and royalty monetization, with a recent $29 million private placement led by CorMedix. End customers are anticipated to be hospital ICUs, nephrology departments, and perioperative care providers accessed through hospital pharmacy procurement and group purchasing organizations.

Name

Talphera

Legal name

Talphera, Inc.

Website

https://talphera.com

Company type

Public

Founded year

2005

Operating status

Operating

Headcount range

11–50 employees

Short description

Talphera is a specialty pharmaceutical company developing therapies for medically supervised settings, with lead candidate Niyad (nafamostat) positioned as the first FDA-approved regional anticoagulant for continuous renal replacement therapy in hospital ICUs. The company also holds royalty rights to the divested DSUVIA product.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Renal Replacement Therapy Consumables (Bloodlines, Filters, Cartridges) (HLAHAKAH)

akta.pro secondary industries

Rare Renal & Nephrology Disorder Therapies (HLAIAIAI), Generic APIs & Intermediates (Active Ingredients) (HLAIABAG)

Keywords

• Regional anticoagulants
• Renal replacement therapy
• Specialty pharmaceuticals
• Critically ill patients
• Medically supervised settings

Headquarters

HQ city

Redwood City

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. DSUVIA Royalty: 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 United States Department of Defense, and up to $116.5 million in sales-based milestone payments.
2. Niyad (future commercial revenue): Once FDA approved, Niyad would be commercialized as the first FDA-approved regional anticoagulant for the extracorporeal circuit in CRRT, targeting hospitals and ICUs. Currently in late-stage development with PMA submission planned for 2026.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Talphera is a specialty pharmaceutical company developing and commercializing innovative therapies for medically supervised settings. Its lead product candidate, Niyad (nafamostat mesylate), is a lyophilized formulation positioned to become the first FDA-approved regional anticoagulant for the extracorporeal circuit during continuous renal replacement therapy (CRRT) for patients who cannot tolerate heparin or have increased bleeding risk. The company also develops pre-filled syringe products (Fedsyra and PFS-02) for perioperative hypotension and retains royalty rights on the divested DSUVIA product.

Product overview

Talphera is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. The company's portfolio includes Niyad®, its lead product candidate (a lyophilized nafamostat formulation for regional anticoagulation in renal replacement therapy), LTX-608™ (a nafamostat-based candidate for inflammatory and antiviral applications), and two pre-filled syringe candidates (Fedsyra™ and PFS-02) developed in partnership with Laboratoire Aguettant. The company was formerly known as AcelRx Pharmaceuticals and renamed to Talphera following the 2023 divestment of its acute pain product DSUVIA.

Differentiator

Problem solved

Functional benefit

Brands

• Niyad: A lyophilized formulation of nafamostat mesylate positioned to be the first FDA-approved regional anticoagulant for use in the extracorporeal circuit during continuous renal replacement therapy (CRRT).
• LTX-608
• Fedsyra
• PFS-02
• DSUVIA

Products and services

• Niyad (nafamostat mesylate) A lyophilized formulation of nafamostat mesylate positioned to be the first FDA-approved regional anticoagulant for the extracorporeal circuit during continuous renal replacement therapy (CRRT) or intermittent hemodialysis (IHD). It targets hospital intensive care units and nephrology departments treating critically ill patients who cannot tolerate heparin or have increased bleeding risk.
• LTX-608 A nafamostat-based product candidate being investigated for various indications including COVID-19, disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), and acute pancreatitis, leveraging nafamostat's anti-inflammatory and antiviral properties. Regulated as a pharmaceutical.
• Fedsyra A 10 mL ready-to-use pre-filled 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, and improved safety.
• PFS-02 A 10 mL ready-to-use pre-filled syringe of phenylephrine hydrochloride in development for the treatment of hypotension due to vasodilation. Developed in partnership with Laboratoire Aguettant as a ready-to-use alternative to vials and ampules.

Quantifiable outcome

• Meta-analysis published in 2022 demonstrated significant safety and efficacy improvements over current standards of care for nafamostat use in extracorporeal circuit
• +2 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• Laboratoire AguettantsecondaryStrategic or Co-development PartnerPartnership with France-based pharmaceutical company Laboratoire Aguettant for the development of pre-filled syringe product candidates Fedsyra (ephedrine) and PFS-02 (phenylephrine). The partnership is designed to streamline care in clinical settings with ready-to-use prefilled syringes.

Scale indicators8 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• CorMedix: CorMedix is a commercial-stage hospital-focused company developing DefenCath (taurolidine/heparin) for catheter-related bloodstream infections in hemodialysis. It is the lead strategic investor in Talphera with a board seat and is negotiating to acquire the company, making it both a direct strategic peer in the hospital/critical care antimicrobial/anticoagulant space and the most relevant potential acquirer.

Broad incumbents

• Fresenius Medical Care: Fresenius is the world's largest dialysis services and products company, with deep involvement in CRRT, hemodialysis equipment, and renal pharmaceuticals. Talphera's CMO previously worked at Fresenius, and Fresenius represents the dominant incumbent across Talphera's renal replacement therapy customer base.
• Baxter International: Baxter is a major manufacturer of dialysis and CRRT equipment, bloodlines, and replacement fluids used in the extracorporeal circuit. It serves the same hospital ICU customer base that would purchase Niyad and competes broadly in the renal replacement therapy consumables category.
• B. Braun: B. Braun's Avitum division supplies hemodialysis and CRRT products, including anticoagulation solutions, to hospitals globally. It is a broad incumbent competitor in the renal replacement therapy and perioperative injectable markets that overlap with Niyad and Talphera's pre-filled syringe portfolio.
• ICU Medical: ICU Medical manufactures IV therapy, critical care, and oncology infusion products sold to hospital pharmacies and ICUs. It is a broader incumbent in the medically supervised setting where Talphera's pre-filled syringe and injectable candidates would compete.
• Heparin Sodium generic manufacturers (e.g., Pfizer, Sagent): Heparin is the current standard of care regional anticoagulant for CRRT. Major manufacturers of injectable heparin (Pfizer, Sagent, Fresenius Kabi) represent the entrenched incumbent therapy that Niyad is positioning to displace in heparin-intolerant and high-bleeding-risk patients.

Emerging players

• Spectral Medical: Spectral Medical is a late-stage clinical company developing PMX (polymyxin B hemoperfusion) for endotoxemic septic shock in the ICU. It shares Talphera's profile as a small-cap hospital/critical care therapeutics developer targeting a defined ICU patient population with a single near-term regulatory catalyst.
• Outset Medical: Outset Medical develops the Tablo hemodialysis system, marketed for both acute and home dialysis settings. It overlaps with Talphera as a small-cap innovator targeting the renal replacement therapy customer base in hospitals and ICUs.
• AngioDynamics: AngioDynamics is a small-cap medical device company focused on vascular access, thrombus management, and dialysis products. It is comparable to Talphera as a small-cap medical device/healthcare company selling into hospital and specialty care channels.
• Akebia Therapeutics: Akebia Therapeutics is a small-cap renal-focused pharmaceutical company (vadadustat for anemia in CKD) where Talphera's Chairman Adrian Adams also serves as Chairman. It is comparable as a publicly traded, late-clinical/early-commercial renal therapeutics company with a hospital/IC channel focus.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds14 records

Investors7 records

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

M&A1 record

Investments1 record

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

Frequently asked questions about Talphera