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TALPHERA, INC. (TLPH)

Talphera, Inc. is a specialty pharmaceutical company focused on developing and commercializing therapeutic products intended for use in carefully monitored medical environments. Their lead experimental candidate is Niyad, a lyophilized (freeze-dried) formulation of nafamostat. This anticoagulant is currently being assessed under an investigational device exemption for its application in extracorporeal circuits. The company's development pipeline also features LTX-608, a potential anti-inflammatory and antiviral agent being explored for the treatment of numerous conditions, including COVID-19, disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), and acute pancreatitis. Furthermore, Talphera is advancing Fedsyra, a pre-filled syringe containing ephedrine, and PFS-02, a pre-filled syringe containing phenylephrine. Established in 2005, the company was previously known as AcelRx Pharmaceuticals, Inc. It adopted the name Talphera, Inc. in January 2024 and maintains its corporate headquarters in San Mateo, California.

Sector: Pharmaceutical Preparations

Industry: Drug Manufacturers - Specialty & Generic

Talphera, Inc. logo

Talphera, Inc.

NASDAQ:TLPHHealthcare
-3.74%$1.03
AH$1.04+0.97%vs close
Mkt Cap$53.46M
Float38.58M
O/S51.91M
Vol
$ Vol
RVOL
Inst Own46.0%
Earnings
Dilution
Talphera, Inc. logoNASDAQ:TLPH$1.03-3.74%
Phase Distribution
18 lead-sponsored trials·1 active·17 completed
Phase 14
Phase 26
Phase 37
Not applicable1
Status Overview
Recruiting1
Completed17

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Status
Phase
  • Phase 3
    Completed

    A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

    Sufentanil NanoTab PCA System/15 mcg, morphine IV PCA

    Post-Operative Pain

    Enrollment
    357
    Start
    Apr 2012
    Primary Completion
    Dec 2012
    Completion
    Dec 2012
    NCT01539538
  • Phase 3
    Completed

    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery

    Sufentanil NanoTab PCA System/15 mcg, Placebo Sufentanil NanoTab PCA System

    Post-Operative Pain

    Enrollment
    172
    Start
    Feb 2012
    Primary Completion
    Jan 2013
    Completion
    Feb 2013
    NCT01539642
  • Phase 3
    Completed

    Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 mcg (Zalviso™) for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery

    Sufentanil NanoTab PCA System/15 mcg, Placebo Sufentanil NanoTab PCA System

    Post Operative Pain

    Enrollment
    419
    Start
    Aug 2012
    Primary Completion
    Apr 2013
    Completion
    May 2013
    NCT01660763
  • Phase 3
    Completed

    A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery

    Sufentanil Tablet 30 mcg, Placebo Tablet

    Post-Operative Pain

    Enrollment
    161
    Start
    Feb 2015
    Primary Completion
    Jun 2015
    Completion
    Aug 2015
    NCT02356588
  • Phase 3
    Completed

    Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain

    sufentanil sublingual 30 mcg tablet

    Moderate-to-severe Acute Pain

    Enrollment
    76
    Start
    Oct 2015
    Primary Completion
    Jun 2016
    Completion
    Jul 2016
    NCT02447848
  • Phase 3
    Completed

    A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain

    sufentanil sublingual tablet 30 mcg

    Acute Moderate-to-severe Pain

    Enrollment
    140
    Start
    Mar 2016
    Primary Completion
    Jun 2016
    Completion
    Jul 2016
    NCT02662556
  • Phase 3
    Completed

    Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg

    Zalviso™ 15 mcg

    Moderate-to-severe Acute Pain

    Enrollment
    320
    Start
    Sep 2016
    Primary Completion
    Apr 2017
    Completion
    May 2017
    NCT02662764
  • Phase 2
    Completed

    A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Elective Unilateral Total Knee Replacement

    Sufentanil NanoTab, Placebo NanoTab

    Post Operative Pain

    Enrollment
    94
    Start
    Mar 2008
    Primary Completion
    Oct 2008
    Completion
    Oct 2008
    NCT00612534
  • Phase 2
    Completed

    A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Major Abdominal Surgery

    Oral sufentanil, Placebo

    Major Upper or Lower Abdominal Surgery

    Enrollment
    88
    Start
    Aug 2008
    Primary Completion
    Mar 2009
    Completion
    Mar 2009
    NCT00718081
  • Phase 2
    Completed

    A Study for the Evaluation of the Safety, Tolerability, and Efficacy of ARX-F02 (Sufentanil NanoTab) Compared to Placebo in the Treatment of Cancer Breakthrough Pain

    Sublingual sufentanil NanoTabs™ and placebo NanoTabs™

    Cancer, Pain

    Enrollment
    34
    Start
    Apr 2009
    Primary Completion
    Mar 2010
    Completion
    Mar 2010
    NCT00833040
  • Phase 2
    Completed

    An Open-Label Functionality, Safety and Efficacy Study in Patients Undergoing Elective Unilateral Knee Replacement

    Sufentanil NanoTab PCA System/15 mcg

    Pain, Postoperative

    Enrollment
    30
    Start
    Apr 2009
    Primary Completion
    Aug 2009
    Completion
    Aug 2009
    NCT00859313
  • Phase 2
    Completed

    A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction Procedure

    Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03), Placebo NanoTab™

    Sedation, Anxiety +1

    Enrollment
    40
    Start
    Jun 2009
    Primary Completion
    Sep 2009
    Completion
    Sep 2009
    NCT00894699
  • Phase 2
    Completed

    Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy

    Sufentanil NanoTab 20 mcg, Sufentanil NanoTab 30 mcg

    Acute Pain

    Enrollment
    101
    Start
    Oct 2012
    Primary Completion
    Feb 2013
    Completion
    Feb 2013
    NCT01710345
  • Phase 1
    Completed

    Effect of Delivery Route on PK of Sufentanil NanoTab

    Treatment A: Sufentanil IV, Treatment B: Sufentanil NanoTab Sublingual

    Pharmacokinetics

    Enrollment
    25
    Start
    Jul 2012
    Primary Completion
    Jul 2012
    Completion
    Jul 2012
    NCT01639729
  • Phase 1
    Completed

    Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

    Sufentanil NanoTab (SUF NT) 15 mcg, Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg

    Pharmacokinetics

    Enrollment
    19
    Start
    Nov 2012
    Primary Completion
    Dec 2012
    Completion
    Dec 2012
    NCT01721070
  • Phase 1
    Completed

    Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

    Single dose of SUF NT 15 mcg, 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes

    Plasma Concentrations

    Enrollment
    40
    Start
    Jan 2013
    Primary Completion
    Feb 2013
    Completion
    Feb 2013
    NCT01761565
  • Phase 1
    Completed

    Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects

    Treatment Arm A: Sufenta®, Treatment B: Sufentanil SSM 30 mcg

    Healthy

    Enrollment
    40
    Start
    May 2014
    Primary Completion
    May 2014
    Completion
    May 2014
    NCT02082236
  • Not applicable
    Recruiting

    Nafamostat Efficacy in Phase 3 Registrational CRRT Study

    Niyad (nafamostat mesylate), Placebo (0.9% NaCl)

    Acute Kidney Injury

    Enrollment
    70
    Start
    Aug 2024
    Primary Completion
    Dec 2025est.
    Completion
    Dec 2025est.
    NCT06150742
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