Naltrexone - Immune Therapeutics

Drug Profile

Naltrexone - Immune Therapeutics

Alternative Names: IRT-103; IRT-104; LDN - Immune Therapeutics; Lodonal; Low-dose naltrexone - Immune Therapeutics

Latest Information Update: 22 Mar 2017

Price : $50

At a glance

  • Originator Nonindustrial source
  • Developer GB Pharma Holdings; Immune Therapeutics; Penn State Milton S. Hershey Medical Center
  • Class Analgesics; Cyclopropanes; Drug withdrawal therapies; Irritable bowel syndrome therapies; Morphinans; Small molecules
  • Mechanism of Action Opioid receptor antagonists
  • Orphan Drug Status

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

    Yes - Ulcerative colitis; Crohn's disease
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Autoimmune disorders; Cancer
  • Registered HIV infections
  • Phase II Crohn's disease
  • Clinical Phase Unknown Cervical cancer

Most Recent Events

  • 17 Mar 2017 Immune Therapeutics announces intention to submit an NDA for Naltrexone (Lodonal™) for HIV infections in Kenya in 2017
  • 07 Mar 2017 Immune Therapeutics enter into an agreement with Omaera Pharmaceuticals and GB Pharma Holdings for the distribution of naltrexone (Lodonal™) in Kenya
  • 07 Mar 2017 Clinical trials in HIV infections in Kenya (PO) before March 2017
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