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FDA Approved Drugs: Changes to Approved Drugs01:26

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Milsaperidone: First Approval.

Matt Shirley1

  • 1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. cdi@adis.com.

Clinical Drug Investigation
|May 29, 2026
PubMed
Summary
This summary is machine-generated.

Milsaperidone, an active metabolite of iloperidone, is a new atypical antipsychotic approved for schizophrenia and bipolar I disorder. Clinical trials confirmed its bioequivalence, paving the way for its US market entry.

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Area of Science:

  • Psychiatry and Pharmacology
  • Neuroscience
  • Drug Development

Background:

  • Milsaperidone is an atypical antipsychotic developed for schizophrenia, bipolar I disorder, and major depressive disorder.
  • It is the active metabolite of iloperidone, an existing atypical antipsychotic.
  • Iloperidone is approved for schizophrenia (since 2009) and acute treatment of bipolar I disorder (since 2024).

Purpose of the Study:

  • To summarize the development milestones of milsaperidone.
  • To highlight its recent US approval for schizophrenia and bipolar I disorder.

Main Methods:

  • Review of clinical trial data demonstrating pharmacokinetic bioequivalence between milsaperidone and iloperidone.
  • Summary of regulatory milestones leading to US approval.

Main Results:

  • Milsaperidone demonstrated pharmacokinetic bioequivalence to iloperidone.
  • US approval granted on February 20, 2026, for schizophrenia and acute manic/mixed episodes of bipolar I disorder in adults.

Conclusions:

  • Milsaperidone represents a significant advancement in the treatment of schizophrenia and bipolar I disorder.
  • Further clinical evaluation is ongoing for major depressive disorder.