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Related Experiment Videos

Iloperidone (Novartis).

J M Keppel Hesselink1

  • 1Universitat Witten/Herdecke, Alfred-Herrhausen-Strasse 50, 58448 Witten, Germany. abfab@jmulder.demon.nl

Idrugs : the Investigational Drugs Journal
|July 16, 2003
PubMed
Summary

Iloperidone, a mixed 5-HT(2a)/D2 antagonist, is in late-stage development for schizophrenia. Novartis anticipates a mid-2004 launch, with a depot formulation also in trials.

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Area of Science:

  • Pharmacology
  • Neuroscience
  • Psychiatry

Background:

  • Iloperidone (HP-873) is a mixed serotonin 5-HT(2a) and dopamine D2 receptor antagonist.
  • It was initially developed by Hoechst Marion Roussel and later licensed to Titan Pharmaceuticals before Novartis acquired development rights.

Purpose of the Study:

  • To outline the development status and projected timeline for iloperidone, a novel antipsychotic agent.
  • To track the progression of iloperidone through clinical trials and regulatory filings.

Main Methods:

  • Review of clinical trial phases (Phase II and III) and regulatory submission timelines.
  • Analysis of licensing agreements and partnership developments between pharmaceutical companies.
  • Inclusion of market analysis and sales projections from financial institutions.

Main Results:

  • Iloperidone progressed through Phase III trials, with anticipated New Drug Application (NDA) filing in mid-2003 and a projected launch in mid-2004.
  • A long-acting injectable depot formulation for monthly administration was in Phase II trials.
  • Financial analysts predicted a 60% likelihood of market entry in 2004, with projected peak sales of $400 million by 2011.

Conclusions:

  • Iloperidone development by Novartis faced several timeline revisions, indicating the complexities of pharmaceutical development.
  • The compound's progression through late-stage trials and the development of a depot formulation suggest its potential as a significant treatment for schizophrenia.
  • Market projections indicate strong commercial potential if regulatory approval is obtained.

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