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Acetazolamide 500mg
Acetazolamide 500mg is a Small molecule drug developed by Puerta de Hierro University Hospital. It is currently in Phase 2 development.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Acetazolamide 500mg |
|---|---|
| Sponsor | Puerta de Hierro University Hospital |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
- Sleepiness
- Paresthesia
- Fatigue
- Polyuria
- Bad Dreams
- Cloudy Urine
- Dizziness
- Rash
- Abnormal Taste when Drinking Carbonated Beverages
- Gastrointestinal Upset
- Hand Pain
- Headache
Key clinical trials
- Preoperative Acetazolamide (PHASE4)
- Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY)
- Acetazolamide for Obstructive Sleep Apnea to Improve Heart Health (PHASE2)
- Diuretic Strategies in Acute Heart Failure Patients at High Risk for Diuretic Resistance (PHASE4)
- Assessing the Clinical Outcomes of Dapagliflozin Versus Acetazolamide in Patients With Acute Heart Failure (PHASE2, PHASE3)
- Patient-centered and Neurocognitive Outcomes with Acetazolamide for Sleep Apnea (PHASE2)
- Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload (PHASE4)
- Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Acetazolamide 500mg CI brief — competitive landscape report
- Acetazolamide 500mg updates RSS · CI watch RSS
- Puerta de Hierro University Hospital portfolio CI
Frequently asked questions about Acetazolamide 500mg
What is Acetazolamide 500mg?
Who makes Acetazolamide 500mg?
What development phase is Acetazolamide 500mg in?
What are the side effects of Acetazolamide 500mg?
Related
- Manufacturer: Puerta de Hierro University Hospital — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing