| Symbol | TLPH |
|---|---|
| Name | TALPHERA, INC. |
| Sector | HEALTH CARE |
| Region | North America |
| Industry | Biotechnology: Pharmaceutical Preparations |
| Address | 25821 INDUSTRIAL BOULEVARD,SUITE 400, HAYWARD, California, 94545, United States |
| Telephone | +1 650 216-3500 |
| Fax | — |
| — | |
| Website | https://www.talphera.com |
| Incorporation | UNDEFINED |
| Incorporated On | — |
| Employees | — |
| Fiscal Year | — |
| Public Since | — |
| Exchanges | NASDAQ |
| Auditor | — |
| Audit Status | NOT PROVIDED |
| Reporting Status | — |
| CIK | 0001427925 |
| Description | Talphera, Inc., formerly AcelRx Pharmaceuticals, Inc., is a specialty pharmaceutical company. The Company is focused on the development and commercialization of therapies for use in medically supervised settings. The Companys nafamostat product candidates include Niyad and LTX-608. Niyad is focused on developing regional anticoagulants for injection into the extracorporeal circuit, such as the dialysis circuit during continuous renal replacement therapy (CRRT) for acute kidney injury (AKI) patients in the hospital, and for chronic kidney disease patients undergoing intermittent hemodialysis (IHD) in dialysis centers. LTX-608 is nafamostat formulation for direct intravenous (IV) infusion that shall be investigated and developed as a potential anti-viral for the treatment of COVID, acute respiratory distress syndrome (ARDS) disseminated intravascular coagulation (DIC), and acute pancreatitis. The Company is also engaged in developing two pre-filled syringes, namely Fedsyra and PFS-02. Additional info from NASDAQ: |
NASDAQ traded attribute type Financial_Status was changed. Previous value: Deficient. New value: Normal.
Read moreNASDAQ symbol attribute type Financial_Status was changed. Previous value: Deficient. New value: Normal.
Read moreWAN MARK A 🟢 acquired 35.8K shares (1 derivative) of TALPHERA, INC. (TLPH) at $0.98 Transaction Date: Jun 22, 2026 | Filing ID: 000002
Read moreTodisco Joseph 🟢 acquired 35.8K shares (1 derivative) of TALPHERA, INC. (TLPH) at $0.98 Transaction Date: Jun 22, 2026 | Filing ID: 000005
Read moreJAIN ABHINAV 🟢 acquired 35.8K shares (1 derivative) of TALPHERA, INC. (TLPH) at $0.98 Transaction Date: Jun 22, 2026 | Filing ID: 000002
Read moreHOFFMAN STEPHEN J 🟢 acquired 35.8K shares (1 derivative) of TALPHERA, INC. (TLPH) at $0.98 Transaction Date: Jun 22, 2026 | Filing ID: 000002
Read moreBroadfoot Jill Marie 🟢 acquired 35.8K shares (1 derivative) of TALPHERA, INC. (TLPH) at $0.98 Transaction Date: Jun 22, 2026 | Filing ID: 000002
Read moreBozilenko Marina 🟢 acquired 35.8K shares (1 derivative) of TALPHERA, INC. (TLPH) at $0.98 Transaction Date: Jun 22, 2026 | Filing ID: 000002
Read moreADAMS ADRIAN 🟢 acquired 35.8K shares (1 derivative) of TALPHERA, INC. (TLPH) at $0.98 Transaction Date: Jun 22, 2026 | Filing ID: 000003
Read more| Trial ID | Title | Phase | Indication | Status | Start Date | Completion Date | Source |
|---|---|---|---|---|---|---|---|
| NCT06150742 | Nafamostat Efficacy in Phase 3 Registrational CRRT Study | Na | Acute Kidney Injury | Recruiting | 2024-08-15 | 2025-12-01 | ClinicalTrials.gov |
| NCT02662764 | Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Su… | Phase3 | Moderate-to-severe Acute Pain | Completed | 2016-09-28 | 2017-05-05 | ClinicalTrials.gov |
| NCT02662556 | A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufe… | Phase3 | Acute Moderate-to-severe Pain | Completed | 2016-03-01 | 2016-07-01 | ClinicalTrials.gov |
| NCT02447848 | Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for A… | Phase3 | Moderate-to-severe Acute Pain | Completed | 2015-10-01 | 2016-07-01 | ClinicalTrials.gov |
| NCT02356588 | A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet … | Phase3 | Post-Operative Pain | Completed | 2015-02-01 | 2015-08-01 | ClinicalTrials.gov |
| NCT02082236 | Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Heal… | Phase1 | Healthy | Completed | 2014-05-01 | 2014-05-01 | ClinicalTrials.gov |
| NCT01761565 | Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab | Phase1 | Plasma Concentrations | Completed | 2013-01-01 | 2013-02-01 | ClinicalTrials.gov |
| NCT01721070 | Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics | Phase1 | Pharmacokinetics | Completed | 2012-11-01 | 2012-12-01 | ClinicalTrials.gov |
| NCT01710345 | Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Followin… | Phase2 | Acute Pain | Completed | 2012-10-01 | 2013-02-01 | ClinicalTrials.gov |
| NCT01660763 | Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 mcg… | Phase3 | Post Operative Pain | Completed | 2012-08-01 | 2013-05-01 | ClinicalTrials.gov |
| NCT01639729 | Effect of Delivery Route on PK of Sufentanil NanoTab | Phase1 | Pharmacokinetics | Completed | 2012-07-01 | 2012-07-01 | ClinicalTrials.gov |
| NCT01539538 | A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Effi… | Phase3 | Post-Operative Pain | Completed | 2012-04-01 | 2012-12-01 | ClinicalTrials.gov |
| NCT01539642 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate t… | Phase3 | Post-Operative Pain | Completed | 2012-02-01 | 2013-02-01 | ClinicalTrials.gov |
| NCT00894699 | A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 S… | Phase2 | Sedation | Completed | 2009-06-01 | 2009-09-01 | ClinicalTrials.gov |
| NCT00859313 | An Open-Label Functionality, Safety and Efficacy Study in Patients Undergoing E… | Phase2 | Pain, Postoperative | Completed | 2009-04-01 | 2009-08-01 | ClinicalTrials.gov |
| NCT00833040 | A Study for the Evaluation of the Safety, Tolerability, and Efficacy of ARX-F02… | Phase2 | Cancer | Completed | 2009-04-01 | 2010-03-01 | ClinicalTrials.gov |
| NCT00718081 | A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Cli… | Phase2 | Major Upper or Lower Abdominal Surgery | Completed | 2008-08-01 | 2009-03-01 | ClinicalTrials.gov |
| NCT00612534 | A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Cli… | Phase2 | Post Operative Pain | Completed | 2008-03-01 | 2008-10-01 | ClinicalTrials.gov |
| Product Name | Type | Development Stage | Therapeutic Area | Study Status | Trial ID |
|---|---|---|---|---|---|
| Placebo Tablet | Other | Phase PHASE3 | Post-Operative Pain | COMPLETED | NCT02356588 |
| Sufentanil Tablet 30 mcg | Other | Phase PHASE3 | Post-Operative Pain | COMPLETED | NCT02356588 |
| Treatment D: SSM 30 mcg | Drug | Phase PHASE1 | Healthy | COMPLETED | NCT02082236 |
| Treatment C: SSM 15 mcg | Drug | Phase PHASE1 | Healthy | COMPLETED | NCT02082236 |
| Treatment B: Sufentanil SSM 30 mcg | Drug | Phase PHASE1 | Healthy | COMPLETED | NCT02082236 |
| Treatment Arm A: Sufenta® | Drug | Phase PHASE1 | Healthy | COMPLETED | NCT02082236 |
| Placebo NanoTab | Other | Phase PHASE2 | Acute Pain | COMPLETED | NCT01710345 |
| Sufentanil NanoTab 30 mcg | Other | Phase PHASE2 | Acute Pain | COMPLETED | NCT01710345 |
| Sufentanil NanoTab 20 mcg | Other | Phase PHASE2 | Acute Pain | COMPLETED | NCT01710345 |
| 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes | Other | Phase PHASE1 | Plasma Concentrations | COMPLETED | NCT01761565 |
| Single dose of SUF NT 15 mcg | Other | Phase PHASE1 | Plasma Concentrations | COMPLETED | NCT01761565 |
| Treatment D: Sufentanil NanoTab Oral | Drug | Phase PHASE1 | Pharmacokinetics | COMPLETED | NCT01639729 |
| Treatment C: Sufentanil NanoTab Buccal | Drug | Phase PHASE1 | Pharmacokinetics | COMPLETED | NCT01639729 |
| Treatment B: Sufentanil NanoTab Sublingual | Drug | Phase PHASE1 | Pharmacokinetics | COMPLETED | NCT01639729 |
| Treatment A: Sufentanil IV | Drug | Phase PHASE1 | Pharmacokinetics | COMPLETED | NCT01639729 |
| morphine IV PCA | Other | Phase PHASE3 | Post-Operative Pain | COMPLETED | NCT01539538 |
| Sufentanil NanoTab PCA System/15 mcg | Other | Phase PHASE3 | Post-Operative Pain | COMPLETED | NCT01539538 |
| Placebo Sufentanil NanoTab PCA System | Other | Phase PHASE3 | Post Operative Pain | COMPLETED | NCT01660763 |
| Sufentanil NanoTab PCA System/15 mcg | Other | Phase PHASE3 | Post Operative Pain | COMPLETED | NCT01660763 |
| Placebo Sufentanil NanoTab PCA System | Other | Phase PHASE3 | Post-Operative Pain | COMPLETED | NCT01539642 |
| Sufentanil NanoTab PCA System/15 mcg | Other | Phase PHASE3 | Post-Operative Pain | COMPLETED | NCT01539642 |
| Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg | Other | Phase PHASE1 | Pharmacokinetics | COMPLETED | NCT01721070 |
| Sufentanil NanoTab (SUF NT) 15 mcg | Other | Phase PHASE1 | Pharmacokinetics | COMPLETED | NCT01721070 |
| sufentanil sublingual tablet 30 mcg | Other | Phase PHASE3 | Acute Moderate-to-severe Pain | COMPLETED | NCT02662556 |
| sufentanil sublingual 30 mcg tablet | Other | Phase PHASE3 | Moderate-to-severe Acute Pain | COMPLETED | NCT02447848 |
| Zalviso™ 15 mcg | Other | Phase PHASE3 | Moderate-to-severe Acute Pain | COMPLETED | NCT02662764 |
| Placebo (0.9% NaCl) | Other | Approved | Acute Kidney Injury | RECRUITING | NCT06150742 |
| Niyad (nafamostat mesylate) | Other | Approved | Acute Kidney Injury | RECRUITING | NCT06150742 |
| Placebo (0.9% NaCl) | DEVICE | Approved | Acute Kidney Injury | RECRUITING | NCT06150742 |
| Niyad (nafamostat mesylate) | DEVICE | Approved | Acute Kidney Injury | RECRUITING | NCT06150742 |
| Zalviso™ 15 mcg | DRUG | Phase PHASE3 | Moderate-to-severe Acute Pain | COMPLETED | NCT02662764 |
| sufentanil sublingual tablet 30 mcg | DRUG | Phase PHASE3 | Acute Moderate-to-severe Pain | COMPLETED | NCT02662556 |
| sufentanil sublingual 30 mcg tablet | DRUG | Phase PHASE3 | Moderate-to-severe Acute Pain | COMPLETED | NCT02447848 |
| Placebo Tablet | DRUG | Phase PHASE3 | Post-Operative Pain | COMPLETED | NCT02356588 |
| Sufentanil Tablet 30 mcg | DRUG | Phase PHASE3 | Post-Operative Pain | COMPLETED | NCT02356588 |
| Treatment D: SSM 30 mcg | DRUG | Phase PHASE1 | Healthy | COMPLETED | NCT02082236 |
| Treatment C: SSM 15 mcg | DRUG | Phase PHASE1 | Healthy | COMPLETED | NCT02082236 |
| Treatment B: Sufentanil SSM 30 mcg | DRUG | Phase PHASE1 | Healthy | COMPLETED | NCT02082236 |
| Treatment Arm A: Sufenta® | DRUG | Phase PHASE1 | Healthy | COMPLETED | NCT02082236 |
| 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes | DRUG | Phase PHASE1 | Plasma Concentrations | COMPLETED | NCT01761565 |
| Single dose of SUF NT 15 mcg | DRUG | Phase PHASE1 | Plasma Concentrations | COMPLETED | NCT01761565 |
| Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg | DRUG | Phase PHASE1 | Pharmacokinetics | COMPLETED | NCT01721070 |
| Sufentanil NanoTab (SUF NT) 15 mcg | DRUG | Phase PHASE1 | Pharmacokinetics | COMPLETED | NCT01721070 |
| Sufentanil NanoTab 30 mcg | DRUG | Phase PHASE2 | Acute Pain | COMPLETED | NCT01710345 |
| Sufentanil NanoTab 20 mcg | DRUG | Phase PHASE2 | Acute Pain | COMPLETED | NCT01710345 |
| Treatment D: Sufentanil NanoTab Oral | DRUG | Phase PHASE1 | Pharmacokinetics | COMPLETED | NCT01639729 |
| Treatment C: Sufentanil NanoTab Buccal | DRUG | Phase PHASE1 | Pharmacokinetics | COMPLETED | NCT01639729 |
| Treatment B: Sufentanil NanoTab Sublingual | DRUG | Phase PHASE1 | Pharmacokinetics | COMPLETED | NCT01639729 |
| Treatment A: Sufentanil IV | DRUG | Phase PHASE1 | Pharmacokinetics | COMPLETED | NCT01639729 |
| Placebo Sufentanil NanoTab PCA System | DRUG | Phase PHASE3 | Post Operative Pain | COMPLETED | NCT01660763 |
| morphine IV PCA | DRUG | Phase PHASE3 | Post-Operative Pain | COMPLETED | NCT01539538 |
| Sufentanil NanoTab PCA System/15 mcg | DRUG | Phase PHASE3 | Post Operative Pain | COMPLETED | NCT01660763 |
| Placebo | DRUG | Phase PHASE2 | Major Upper or Lower Abdominal Surgery | COMPLETED | NCT00718081 |
| Oral sufentanil | DRUG | Phase PHASE2 | Major Upper or Lower Abdominal Surgery | COMPLETED | NCT00718081 |
| Placebo NanoTab™ | DRUG | Phase PHASE2 | Sedation | COMPLETED | NCT00894699 |
| Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03) | DRUG | Phase PHASE2 | Sedation | COMPLETED | NCT00894699 |
| Sublingual sufentanil NanoTabs™ and placebo NanoTabs™ | DRUG | Phase PHASE2 | Cancer | COMPLETED | NCT00833040 |
| Placebo NanoTab | DRUG | Phase PHASE2 | Acute Pain | COMPLETED | NCT01710345 |
| Sufentanil NanoTab | DRUG | Phase PHASE2 | Post Operative Pain | COMPLETED | NCT00612534 |