Data updated: Sep 20, 2026
ZENBEXUS (iberdomide hydrochloride) · Bristol-Myers Squibb
Approved 2026-08-13
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2026-08-13
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ZENBEXUS Approval History
Original
New Indication
New Form
Label Update
2 FDA actions from 2026 to 2026
What ZENBEXUS Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
Bristol-Myers Squibb's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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2022 MAVACAMTEN
3 designations
SOTYKTU
2022 DEUCRAVACITINIB
1 designation
KRAZATI
2022 ADAGRASIB
4 designations
OPDUALAG
2022 NIVOLUMAB
4 designations
ZEPOSIA
2020 OZANIMOD HYDROCHLORIDE
REBLOZYL
2019 LUSPATERCEPT-AAMT
4 designations
INREBIC
2019 FEDRATINIB HYDROCHLORIDE
2 designations
IDHIFA
2017 ENASIDENIB MESYLATE
4 designations
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04776395 | STUDY00001731 NCI-2020-08351, WINSHIP5157-20 | Ph 2 | recruiting | Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZENBEXUS FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.