Data updated: May 26, 2026
DIAMOX (acetazolamide)
Trial Activity: Stable 23 active trials
Cardiovascular
Approved 1953-07-27
Development Insights
University of Zurich conducting 8 trials (11%)
77 indications explored (Broad Platform)
→ obstructive sleep apnea (11 trials)
→ acute mountain sickness (6 trials)
→ acute decompensated heart failure (4 trials)
3
Indications
--
Phase 3 Trials
1
Priority Reviews
72
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1953-07-27
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE, CAPSULE, EXTENDED RELEASE
DIAMOX Approval History
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Original
New Indication
New Form
Label Update
97 FDA actions from 1953 to 2025
Apr 2014 SUPPL
Mfg
Mar 2014 SUPPL
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Jul 2003 SUPPL
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Jun 1977 SUPPL Priority
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Jan 1977 SUPPL Priority
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Jan 1962 ORIGINAL
Update
Jun 1954 ORIGINAL
New Form
Jul 1953 ORIGINAL Priority
New Drug
What DIAMOX Treats
3 FDA approvalsOriginally approved for its first indication in 1953 . Covers 3 distinct patient populations.
- Other (3)
Other
(3 approvals)- • Approved indication (Jul 1953) Priority
- • Approved indication (Jun 1954)
- • Approved indication (Jan 1962)
📋
Clinical Trial Registry
71 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05804084 PANACEA | 802041 K23HL161336 | Ph 2 | recruiting | Patient-centered and Neurocognitive Outcomes With Acetazolamide for Sleep Apnea |
| NCT04975269 DRAIN | NPH-01 | Ph 2 | completed | Acetazolamide Trial in Normal Pressure Hydrocephalus |
| NCT06776432 | SVA-SAS-201 | Ph 2 | active not recruiting | Safety and Efficacy Study of Sivopixant, Acetazolamide and SASS-001 in Sleep Apnea |
| NCT03011671 | IRB16-0767 | Ph 1 | active not recruiting | Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma |
| NCT05470283 | 2022-0356 NCI-2022-06873 | Ph 1 | active not recruiting | Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma |
| NCT04887792 APTS | STUDY20010237 | Ph 1, Ph 2 | recruiting | Acetazolamide for Treatment Resistant Schizophrenia |
| NCT06043830 MORPHO | 201743.2 K23HL151880 | Ph 2 | completed | Managing Opioid Related Sleep Apnea With Acetazolamide |
| NCT07372040 | Acute Heart Failure 2026 | Ph 2 | recruiting | Add-on Diuretics in Acute Decompensated Heart Failure |
| NCT06499727 | HighCycle_AMS | Ph 4 | completed | HighCycle Study: Effect of Acetazolamide on Acute Mountain Sickness in Women Compared to Men |
| NCT05589792 RemmOSA | 2022p002458 | Ph 1, Ph 2 | completed | Acetazolamide on REM OSA |
| NCT05616260 ACE-Of-HEARTs | 804081 | Ph 2 | completed | Acetazolamide for Obstructive Sleep Apnea to Improve Heart Health |
| NCT06521476 | STUDY23100016 R01DA059465 | Ph 2 | recruiting | Acetazolamide in Central Sleep Apnea Patients Using Medication for Opioid Use Disorder |
| NCT04726982 | B3002021000015 | Ph 4 | completed | Optimal Dosage of Acetazolamide for OSA Treatment |
| NCT02703220 | PULM-008-14F | Ph 4 | recruiting | Sleep Apnea in Elderly |
| NCT02390284 STOP-RGCD results posted | 20140587 R01EY014957 | Ph 3 | terminated | Stop Retinal Ganglion Cell Dysfunction Study |
| NCT07118462 | HighCycle_PV | Ph 4 | recruiting | HighCycle Study: Acetazolamide, High Altitude and Plasma Volume |
| NCT05589753 SDB | PULM-003-18F 1904002203 | Ph 1, Ph 2 | recruiting | Sleep Disordered Breathing With Opioid Use |
| NCT06981234 | 802153-2 | Ph 2 | recruiting | Acetazolamide in Persons With Type 1 Diabetes - Crossover Trial |
| NCT06498505 | HighCycle_PAP | Ph 4 | recruiting | HighCycle: Effect of Acetazolamide on Pulmonary Artery Pressure in Women Compared to Men |
| NCT06498531 | HighCycle_SDB | Ph 4 | recruiting | HighCycle Study: Effect of Acetazolamide on Sleep Disordered Breathing in Women Compared to Men |
| NCT06114537 AXIS | NL80249.018.22 | Ph 2 | completed | The AXIS Study: the Efficacy of Acetazolamide for the Treatment of Cystoid Fluid Collections in Retinoschisis |
| NCT05473364 | UC-MEDJP-05 | Ph 1, Ph 2 | completed | Acetazolamide in Persons With Type 1 Diabetes - Dose Finding |
| NCT06146101 REPOSA | IHL42XOSAP2/3 U1111-1302-4915 | Ph 2, Ph 3 | active not recruiting | RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA |
| NCT02945527 | 62352 | Ph 2, Ph 3 | terminated | Treatment of Peri-calcification Edema in Neurocysticercosis (NCC) |
| NCT05300477 | 21-06HC (M-10910) | Ph 4 | active not recruiting | Pharmacological Countermeasures for High Altitude |
| NCT04679389 results posted | 20-000634 | Ph 2, Ph 3 | terminated | Acetazolamide Efficacy in Ataxia in PMM2-CDG |
| NCT06166654 DRAIN-AHF | DRAIN_AHF | Ph 4 | recruiting | Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload |
| NCT05986773 P-Value-AHF | P-Value-AHF | Ph 4 | terminated | Diuretic Strategies in Acute Heart Failure Patients at High Risk for Diuretic Resistance |
| NCT05802849 ORION-A | 001 | Ph 4 | recruiting | Acetazolamide Per os for Decompensation of Heart Failure |
| NCT03505788 Advor results posted | ZOLCAR17001 | Ph 4 | completed | Acetazolamide in Decompensated Heart Failure With Volume OveRload (ADVOR) |
| NCT06535529 | Acetazolamide vs Dapa in ADHF | Ph 3 | recruiting | Acetazolamide Versus Dapagliflozin in Acute Decompensated Heart Failure Patients |
| NCT06414759 | CL3575 IHC00077 | Ph 4 | recruiting | Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload |
| NCT04227093 ACTOS | B300201942507 | Ph 4 | active not recruiting | Acetazolamide Add-On Therapy to OSA Surgery |
| NCT05293600 RescOSA | 2022p000430 | Ph 1, Ph 2 | recruiting | Rescue Pharmacotherapy for OSA |
| NCT04639193 RESCUE-Combo results posted | 191990 | Ph 2 | completed | Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea |
| NCT06091085 | 2023P002472 | Ph 1, Ph 2 | recruiting | Acetazolamide as a Means to Mitigate Falling Ventilatory Drive and Drive-dependent OSA |
| NCT03377049 results posted | 2017-1510 SMPH/NEURO SURG/NEURO SURG, A535700 | Ph 4 | completed | Acetazolamide Challenge With Perfusion in the Prediction of Cerebral Vasospasm |
| NCT02466074 perfuseMS results posted | HSC-MS-14-0450 | Ph 2 | terminated | Augmenting Cerebral Blood Flow to Treat Established Multiple Sclerosis |
| NCT05023941 | RIPC-Acet-AMS | Ph 4 | completed | Optimization Strategy for the Prevention of AMS by RIPC Combined With Acetazolamide |
| NCT04470843 | PRO00031299 | Ph 1 | completed | Impact of Acetazolamide in Reducing Referred Postoperative Pain |
| NCT03501966 SIGHT results posted | SIGHT 1U10EY025990-01A1 | Ph 3 | terminated | Surgical Idiopathic Intracranial Hypertension Treatment Trial |
| NCT04351061 | 20191265 | Ph 2 | withdrawn | Acetazolamide for the Prevention of Post Operative CSF Leak |
| NCT02755298 ChronicAZA | KEK-ZH-2016-00089-2 | Ph 2, Ph 3 | completed | Chronic Clinical Effect of Acetazolamide |
| NCT02904265 results posted | 16-002442 | Ph 2, Ph 3 | terminated | Efficacy Study of Acetazolamide Versus Diazepam in Continuous Spike and Wave/Landau-Kleffner Syndrome |
| NCT02902133 | 20150742 | Ph 2 | withdrawn | Acetazolamide to Prevent Post Operative CSF Leak |
| NCT02755259 AcuteAZA | KEK-ZH-2016-00089 | Ph 2, Ph 3 | completed | Acute Hemodynamic Effect of Acetazolamide in Pulmonary Hypertension |
| NCT03490916 results posted | H00014860 | Ph 4 | terminated | Effect of Acetazolamide on Subclinical High-Altitude Pulmonary Edema Detected by Lung Ultrasonography |
| NCT02992938 | 803/16 | Ph 4 | completed | Administration of Acetazolamide to Prevent Remifentanil Induced Hyperalgesia |
| NCT02604173 ASPECT results posted | 35330 | Ph 3 | completed | Altitude Sickness Prevention and Efficacy of Comparative Treatments |
| NCT01003639 IIHTT results posted | NORDIC01 1U10EY017281-01A1, 1U10EY017387-01A1 | Ph 2, Ph 3 | completed | Idiopathic Intracranial Hypertension Treatment Trial |
Showing 50 of 71 trials
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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.
DIAMOX FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment