Generic azacitidine tablet tested against Brand-Name onureg in AML patients

NCT ID NCT06326697

Completed Disease control Sponsor: Hikma Pharmaceuticals LLC Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared a generic azacitidine tablet to the brand-name drug Onureg in 32 adults with acute myeloid leukemia (AML) who are in remission. Participants took a single dose of each drug under fasting conditions to see if the generic version is absorbed similarly. The goal is to show the generic is equivalent, which could offer a more affordable treatment option.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: azacitidine (chemotherapy drug)
What this could lead to: If successful, this could provide a more affordable generic version of azacitidine for AML patients in remission.
What could go wrong: This is a small, early-phase bioequivalence study, not a test of effectiveness. It only checks how the drug is absorbed in the body, not whether it improves outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

acute myeloblastic leukemia with maturation acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE MYELOID LEUKAEMIA

Contacts and locations

Locations

King Faisal Specialist Hospital and Research Centre

Riyadh, Saudi Arabia

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