FDA approves Bristol Myers Squibb's Zenbexus, a new molecular entity

The U.S. Food and Drug Administration has approved ZENBEXUS (NDA221075) as an original application, with the active ingredient iberdomide hydrochloride.¹ The application was sponsored by Bristol Myers Squibb.

The drug is formulated as an oral capsule, available in two strengths: one product contains iberdomide hydrochloride equivalent to 1 mg base, and the other contains iberdomide hydrochloride equivalent to 0.75 mg base.¹

The FDA classified this as a Type 1 New Molecular Entity submission and granted it priority review status.¹ The submission status was recorded as AP (approved), with a submission status date of August 13, 2026.¹

According to the application documents, the approval letter is dated August 17, 2026, and the drug label was issued the following day, August 18, 2026.¹ A medication guide was also included as part of the labeling package, referenced within the same label document.

No additional details on the approved indication, clinical trial data, or dosing regimen were included in the available FDA application record. Further specifics on the approved use and prescribing information would be found in the full label document filed with the agency.