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Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Quantitative Structure-Activity Relationship, Activity Prediction, and Molecular Dynamics of Non-nucleotide Reverse Transcriptase Inhibitors
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Onradivir: First Approval.

Arnold Lee1

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

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|September 25, 2025
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Summary
This summary is machine-generated.

Onradivir is a new antiviral drug that effectively inhibits influenza A virus replication. It has received its first approval in China for treating uncomplicated influenza A in adults.

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Area of Science:

  • Virology
  • Pharmacology

Background:

  • Influenza A virus poses a significant public health threat.
  • Development of novel antiviral agents is crucial for managing influenza.
  • Small molecule inhibitors offer targeted therapeutic strategies.

Purpose of the Study:

  • To summarize the development of onradivir, a novel RNA polymerase inhibitor.
  • To highlight the milestones leading to its first regulatory approval.
  • To detail its efficacy in treating uncomplicated influenza A.

Main Methods:

  • Onradivir targets the PB2 cap-binding domain of the influenza A virus RNA polymerase.
  • Phase III clinical trial (NCT04683406) data supported the approval.
  • Development by Guangdong Raynovent Biotech.

Main Results:

  • Onradivir demonstrated potent inhibition of influenza A virus replication.
  • The drug received its first approval in China in May 2025.
  • Efficacy was established in the treatment of uncomplicated influenza A in adults.

Conclusions:

  • Onradivir represents a significant advancement in influenza A treatment.
  • The drug's mechanism of action provides a targeted approach to viral inhibition.
  • Regulatory approval marks a key milestone in making this therapy available.