TheraRadar
Data updated: May 26, 2026

ACETAZOLAMIDE SODIUM

Trial Activity: Stable 23 active trials
Cardiovascular Approved 1995-02-28
Jump to: Indications Approvals Trials Competitors Safety Patents

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)
8
Indications
--
Phase 3 Trials
31
Years on Market

Details

Status
Discontinued
First Approved
1995-02-28
Routes
INJECTION, Injection
Dosage Forms
INJECTABLE, Injectable

Companies

PH HEALTH Hikma Viatris AVET LIFESCIENCES GLAND QUAD PHARMS ZYDUS PHARMS XGEN PHARMS Pfizer
Active Ingredient: ACETAZOLAMIDE SODIUM

ACETAZOLAMIDE SODIUM Approval History

1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
16 FDA actions from 1995 to 2026
May 2026 SUPPL
Label · Labeling
Jun 2025 ORIGINAL
Update
Jul 2024 SUPPL
Label · Labeling

What ACETAZOLAMIDE SODIUM Treats

8 FDA approvals

Originally approved for its first indication in 1995 . Covers 8 distinct patient populations.

  • Other (8)
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

ACETAZOLAMIDE SODIUM FDA Label Details

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Data Sources

FDA Approval: ANDA205358 → Trials: ClinicalTrials.gov →

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