KP 511

Drug Profile

KP 511

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

Latest Information Update: 12 Jan 2017

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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

  • 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
  • 10 Aug 2016 KemPharm plans a human abuse liability programme for KP 511/ER
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