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atorvastatina
atorvastatina is a Small molecule drug developed by Hospital de Clinicas de Porto Alegre. It is currently in Phase 2 development.
Atorvastatina is a small molecule used to treat various conditions, including hypercholesterolemia, and has been studied in clinical trials for other conditions such as polycystic ovary syndrome, hypertension, and non-ST segment elevation acute coronary syndrome. It is available under the brand name Lipitor and has been used in combination with ezetimibe in some clinical trials.
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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 | atorvastatina |
|---|---|
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Atorvastatin Therapy in the Treatment of Dyslipidemia in Children With Steroid Sensitive Nephrotic Syndrome (PHASE4)
- Atorvastatin Therapy on Xanthoma in Alagille Syndrome (PHASE4)
- Atorvastatin in Active Vitiligo (PHASE2)
- A Prospective, Open, Observational Study to Confirm the Lipid-lowering Effect, Changes in Glucose Metabolism, and Safety After 6 Months of Administration of Atostazet to Hypercholesterolemic Patients 65 Years of Age or Older
- A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events (PHASE3)
- Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma (EARLY_PHASE1)
- Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease (NA)
- Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients (PHASE3)
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:
- atorvastatina CI brief — competitive landscape report
- atorvastatina updates RSS · CI watch RSS
- Hospital de Clinicas de Porto Alegre portfolio CI
Frequently asked questions about atorvastatina
What is atorvastatina?
Who makes atorvastatina?
What development phase is atorvastatina in?
Related
- Manufacturer: Hospital de Clinicas de Porto Alegre — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing