Asalhydromorphone - KemPharm

Drug Profile

Asalhydromorphone - KemPharm

Alternative Names: Asal-HM; Hydromorphone extended release - KemPharm; Hydromorphone immediate release - KemPharm; KP 511/ER; KP 511/IR; KP511 API

Latest Information Update: 29 Jan 2018

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At a glance

  • Originator KemPharm
  • Class Morphine derivatives; Opioid analgesics; Small molecules
  • Mechanism of Action Opioid receptor agonists
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Phase I Acute pain

Most Recent Events

  • 23 Jan 2018 KemPharm has patent protection for KP 511 entitled "Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydromorphone, prodrugs, methods of making and use thereof" in USA
  • 09 Jan 2017 KemPharm announces intention to submit two NDAs to US FDA in 2019
  • 09 Jan 2017 Pharmacokinetics, pharmacodynamics and adverse events data from the phase I Study KP511.A01 released by KemPharm
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