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Sufentanil - Talphera

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Drug Profile

Sufentanil - Talphera

Alternative Names: ARX 01; ARX-02; ARX-04; ARX-F01; ARX-F02; DSUVIA; DZUVEO; SST system; Sublingual sufentanil; Sufentanil sublingual; Sufentanil sublingual - NanoTab; Sufentanil sublingual tablet; Sufentanil sublingual tablet system; Zalviso

Latest Information Update: 06 May 2026

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At a glance

  • Originator AcelRx Pharmaceuticals
  • Developer Grunenthal; Talphera
  • Class Amides; General anaesthetics; Opioid analgesics; Piperidines; Small molecules; Thiophenes
  • Mechanism of Action Opioid mu receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No
  • Available For Licensing Yes - Acute pain; Cancer pain; Postoperative pain

Highest Development Phases

  • Marketed Acute pain
  • Suspended Cancer pain

Most Recent Events

  • 31 Dec 2025 Alora Pharmaceuticals submits a letter to the US FDA to request the withdrawal of the DSUVIA NDA
  • 28 May 2025 No recent reports of development identified for clinical-Phase-Unknown development in Acute pain in Unknown (Sublingual, Tablet)
  • 09 Jan 2024 AcelRx Pharmaceuticals is now called Talphera

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