Data updated: May 30, 2026
BAXFENDY (baxdrostat)
Approved 2026-05-15
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2026-05-15
- PDUFA Date
- 2026-06-15 (4d)
- Routes
- ORAL
- Dosage Forms
- TABLET
BAXFENDY Approval History
Original
New Indication
New Form
Label Update
2 FDA actions from 2026 to 2026
What BAXFENDY Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
Other
(1 approval)- • Approved indication (May 2026) Priority NewLabel
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Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06344104 BaxAsia | D6970C00008 | Ph 3 | completed | A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension |
| NCT07007793 BaxPA | D6974C00001 | Ph 3 | recruiting | A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism |
| NCT06168409 Bax24 | D6970C00009 2023-507640-36-00 | Ph 3 | completed | A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension |
| NCT06336356 results posted | D6970C00011 | Ph 2 | completed | A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compared to Placebo in Participants With Uncontrolled Hypertension |
| NCT06034743 BaxHTN | D6970C00002 2023-505499-32-00 | Ph 3 | completed | A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension |
| NCT06194032 | D6970C00004 2023-506108-23-00 | Ph 1 | completed | A Study to Investigate the Effect on QTcF of Baxdrostat Compared With Placebo, Using Moxifloxacin as a Positive Control, in Healthy Participants |
| NCT06657105 | D6970C00006 | Ph 1 | completed | A Study to Investigate the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel When Given Alone and in Combination With Baxdrostat in Healthy Females of Non-childbearing Potential |
| NCT06357520 | D6970C00005 | Ph 1 | completed | A Study to Investigate the Pharmacokinetics of Baxdrostat When Given Alone and in Combination With Itraconazole in Healthy Participants |
| NCT05961384 | CIN-107-117 | Ph 1 | completed | Phase 1 Study to Determine the Metabolism and Clearance of Baxdrostat |
| NCT05961397 | CIN-107-115 | Ph 1 | completed | Phase 1 PK Study to Evaluate the PK of CIN-107 in Subjects With Hepatic Impairment |
| NCT05966324 | CIN-107-126 | Ph 1 | completed | Baxdrostat Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Japanese Population |
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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.
BAXFENDY FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.