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Gemcabene - Gemphire Therapeutics

Drug Profile

Gemcabene - Gemphire Therapeutics

Alternative Names: CI-1027; Gemcabene calcium; PD 0072953; PD 072953

Latest Information Update: 26 Sep 2019

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At a glance

  • Originator Pfizer
  • Developer Emory University; Gemphire Therapeutics; Pfizer
  • Class Antihyperlipidaemics; Antihypertensives; Antirheumatics; Caproates; Hepatoprotectants; Small molecules
  • Mechanism of Action Acetyl-CoA carboxylase inhibitors; Apolipoprotein C-III inhibitors; C-reactive protein inhibitors; CCR2 receptor antagonists; CCR5 receptor antagonists; Lipoprotein A inhibitors; Sulfatase inhibitors
  • Orphan Drug Status

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

    Yes - Hypercholesterolaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Hypercholesterolaemia; Hyperlipoproteinaemia; Hypertension; Hypertriglyceridaemia; Non-alcoholic fatty liver disease; Non-alcoholic steatohepatitis; Osteoarthritis

Most Recent Events

  • 27 Aug 2019 Gemphire Therapeutics and Emory University completes a phase II trial in Non alcoholic fatty liver disease (In children, In adolescents) in USA (NCT03436420)
  • 13 Aug 2019 Gemphire intends to submit additional information to the US FDA in Q4 2019 to request it to lift the partial clinical hold on gemcabene
  • 31 Jul 2019 Gemphire Therapeutics completes the phase II AZURE-1 trial for Nonalcoholic Steatohepatitis (Familial Partial Lipodystrophy) in USA (PO) (NCT03508687)
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