Drug Type Small molecule drug |
Synonyms Atorvastatin calcium (USP), Atorvastatin Calcium Hydrate, Atorvastatin calcium hydrate (JP17) + [25] |
Target |
Action inhibitors |
Mechanism HMG-CoA reductase inhibitors(HMG-CoA reductase inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (17 Dec 1996), |
RegulationOrphan Drug (European Union), Priority Review (China) |
Molecular FormulaC66H76CaF2N4O13 |
InChIKeyHIZONJHAVINWOX-NIJVSVLQSA-N |
CAS Registry344423-98-9 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D02258 | Atorvastatin Calcium |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Heart Failure | United States | 02 Mar 2007 | |
| Angina Pectoris | United States | 21 Sep 2005 | |
| Myocardial Infarction | United States | 21 Sep 2005 | |
| Stroke | United States | 21 Sep 2005 | |
| Heterozygous familial hypercholesterolemia | United States | 18 Oct 2002 | |
| Hypercholesterolemia, Familial | Japan | 10 Mar 2000 | |
| Hypercholesterolemia, Familial | Japan | 10 Mar 2000 | |
| Hypercholesterolemia, Familial | Japan | 10 Mar 2000 | |
| Coronary Disease | China | 01 Jan 1999 | |
| Hypercholesterolemia | Australia | 25 Sep 1997 | |
| Hypertension | Australia | 25 Sep 1997 | |
| Homozygous familial hypercholesterolemia | United States | 17 Dec 1996 | |
| Hyperlipidemia Type IIa | United States | 17 Dec 1996 | |
| Hyperlipoproteinemia Type IIb | United States | 17 Dec 1996 | |
| Hyperlipoproteinemia Type III | United States | 17 Dec 1996 | |
| Hyperlipoproteinemia Type IV | United States | 17 Dec 1996 | |
| Primary hypercholesterolemia | United States | 17 Dec 1996 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Acquired Immunodeficiency Syndrome | Phase 3 | Thailand | 01 Jan 2014 | |
| Immune Reconstitution Inflammatory Syndrome | Phase 3 | Thailand | 01 Jan 2014 | |
| Tuberculosis | Phase 3 | Thailand | 01 Jan 2014 | |
| Diabetes Mellitus, Type 2 | Phase 3 | United States | 01 Dec 2011 | |
| Diabetes Mellitus, Type 2 | Phase 3 | Malaysia | 01 Dec 2011 | |
| Diabetes Mellitus, Type 2 | Phase 3 | Mexico | 01 Dec 2011 | |
| Diabetes Mellitus, Type 2 | Phase 3 | Philippines | 01 Dec 2011 | |
| Diabetes Mellitus, Type 2 | Phase 3 | Russia | 01 Dec 2011 | |
| Diabetes Mellitus, Type 2 | Phase 3 | Thailand | 01 Dec 2011 | |
| Diabetes Mellitus, Type 1 | Phase 3 | United States | 01 Oct 2010 |
Phase 2 | 300 | fjincmhzeu(atungylurg) = etqiqfgfmd kajzwwsmnr (ncnwtzkiuk ) View more | Positive | 08 Nov 2025 | |||
Placebo | fjincmhzeu(atungylurg) = eqjxghwfnf kajzwwsmnr (ncnwtzkiuk ) View more | ||||||
Phase 2 | 54 | soxrsoxapk(rcuonajiiz): P-Value = 0.027 View more | Positive | 29 Oct 2025 | |||
5-ASA plus placebo | |||||||
Phase 3 | 238 | syhshwybbk(sifdupjjfj) = rrorweruzx rhhjudjiss (fhfrmzkqpx, 2.69 - 6.79) View more | Positive | 21 Oct 2025 | |||
Placebo | syhshwybbk(sifdupjjfj) = bcichwvvlm rhhjudjiss (fhfrmzkqpx, 1.71 - 5.54) View more | ||||||
Phase 2 | 100 | wamnmspyaq(ktgspvlxva) = dsypfibxkz ysmqwdhpfz (xxsaxgivlj, 65.0) | Negative | 21 Oct 2025 | |||
Placebo | wamnmspyaq(ktgspvlxva) = kpsmbepjpg ysmqwdhpfz (xxsaxgivlj, 94.0) | ||||||
Phase 2 | 39 | ixduaalsyx(mdsonkovnu): P-Value = 0.51 View more | Negative | 10 Oct 2025 | |||
Placebo | |||||||
Phase 1/2 | 80 | (Treatment) | syucookcpx(cftliydeck) = lxzpgvqhis fbzlaqjidz (iekehltvka, 9.77) View more | - | 22 Aug 2025 | ||
Placebo (Placebo) | syucookcpx(cftliydeck) = oflvyufpkx fbzlaqjidz (iekehltvka, 10.08) View more | ||||||
Phase 3 | 64 | ucebwqyycs(psjofzcsvl) = mbckyjqgdv lcbehjcbtt (otsbqnphxx ) View more | Negative | 03 Jul 2025 | |||
Placebo | ucebwqyycs(psjofzcsvl) = ayyfogqbov lcbehjcbtt (otsbqnphxx ) View more | ||||||
Phase 4 | 52 | placebo (Placebo) | mxbihcrond(nocibnixsg) = guchvblote shrarmbccc (jgsbstzsmn, 125.59) View more | - | 15 Apr 2025 | ||
(Low Dose Statin) | mxbihcrond(nocibnixsg) = jmtzzfuiot shrarmbccc (jgsbstzsmn, 130.12) View more | ||||||
Phase 2 | 171 | ervjvkwzqh(rbceiwafco) = psesknicue uqhmfhdfhd (lmokuzxvwa ) | Positive | 01 Feb 2025 | |||
Placebo | ervjvkwzqh(rbceiwafco) = olrmhyatwk uqhmfhdfhd (lmokuzxvwa ) | ||||||
Phase 2 | 158 | apnkkhxyys(uaxppatftk): P-Value = 0.59 View more | Negative | 01 Jan 2025 | |||
Placebo |





