Data updated: May 26, 2026
AMLODIPINE AND OLMESARTAN MEDOXOMIL (amlodipine besylate)
Cardiovascular
Approved 2016-10-26
12
Indications
--
Phase 3 Trials
9
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2016-10-26
- Routes
- ORAL
- Dosage Forms
- TABLET
AMLODIPINE AND OLMESARTAN MEDOXOMIL Approval History
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
124 FDA actions from 2016 to 2025
May 2025 SUPPL
Label · Labeling
Feb 2025 ORIGINAL
Update
Jun 2024 SUPPL
Label · Labeling
Jun 2023 SUPPL
Label
Jun 2023 SUPPL
Label
Jan 2021 SUPPL
Label
Dec 2020 SUPPL
Label
Oct 2019 SUPPL
Label
Dec 2018 ORIGINAL
Update
Aug 2018 ORIGINAL
Update
Nov 2017 ORIGINAL
Update
Sep 2017 ORIGINAL
Update
Aug 2017 ORIGINAL
Update
Jul 2017 ORIGINAL
Update
Jul 2017 ORIGINAL
Update
May 2017 ORIGINAL
Update
Nov 2016 ORIGINAL
Update
Oct 2016 ORIGINAL
Update
What AMLODIPINE AND OLMESARTAN MEDOXOMIL Treats
12 FDA approvalsOriginally approved for its first indication in 2016 . Covers 12 distinct patient populations.
- Other (12)
Other
(12 approvals)- • Approved indication (Oct 2016)Letter
- • Approved indication (Oct 2016)
- • Approved indication (Nov 2016)
- • Approved indication (May 2017)
- • Approved indication (Jul 2017)
- • Approved indication (Jul 2017)
- • Approved indication (Aug 2017)
- • Approved indication (Sep 2017)
- • Approved indication (Nov 2017)
- • Approved indication (Aug 2018)
- • Approved indication (Dec 2018)
- • Approved indication (Feb 2025)
📋
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04434664 BLOCK HFpEF results posted | 833517 | Ph 4 | completed | BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in HFpEF |
| NCT04974138 CSPPT2-CC/CT | CSPPT2-CC/CT_2020 | Ph 4 | recruiting | China Stroke Primary Prevention Trial 2 for Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT) |
| NCT04974151 CSPPT2-TT | CSPPT2-TT_2020 | Ph 4 | recruiting | China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype |
| NCT05275907 | STU00215781 1R56HL155093-01 | Ph 4 | withdrawn | Mechanism of Hypertension Treatments in Liver Transplant Recipients (BLOCK LTR-HTN) |
| NCT02940548 NARRAS | 2016PHB013-02 | Ph 4 | terminated | Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness |
| NCT01302691 results posted | 0954E-357 | Ph 3 | completed | MK-0954E Study in Participants With Hypertension (MK-0954E-357) |
| NCT02353806 results posted | 042014-059 UL1TR001105 | Ph 4 | completed | Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation |
| NCT01556997 PATH results posted | X985400 | Ph 3 | completed | Perindopril Amlodipine for the Treatment of Hypertension |
🔬
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.
AMLODIPINE AND OLMESARTAN MEDOXOMIL FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.