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atrovastatin
atrovastatin is a Small molecule drug developed by Astellas Pharma Inc. It is currently in Phase 2 development. Also known as: Lipitor.
Atorvastatin is a small molecule used in various clinical trials for conditions such as hypercholesterolemia, leukemia, and Hodgkin disease. It has been studied in combination with ezetimibe and used to investigate cardiotoxicity in patients with acute myeloid leukemia.
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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 | atrovastatin |
|---|---|
| Also known as | Lipitor |
| Sponsor | Astellas Pharma Inc |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis (PHASE2)
- "The Effect of The Combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart Disease"
- Atorvaststin and Cardiotoxicity in Acute Myloid Leukemia (PHASE1, PHASE2)
- Bioequivalence Study Of Pediatric Appropriate Formulation (PHASE1)
- Type 2 Diabetic Patients Maintained on Statin Therapy (PHASE4)
- The Effects of Statin on Postoperative Renal Function in Valvular Heart Surgery: a Randomized, Placebo-controlled Study (NA)
- Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin (PHASE1)
- Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents (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:
- atrovastatin CI brief — competitive landscape report
- atrovastatin updates RSS · CI watch RSS
- Astellas Pharma Inc portfolio CI
Frequently asked questions about atrovastatin
What is atrovastatin?
Who makes atrovastatin?
Is atrovastatin also known as anything else?
What development phase is atrovastatin in?
Related
- Manufacturer: Astellas Pharma Inc — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Lipitor
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing