Wednesday, July 8, 2026

Drug profile · INN

simvastatin

simvastatin (APO-SIMVASTATIN) is a hmg-coa reductase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved NMPA: clinical trials
US status approved
Patents linked 6
Pipeline programs 14
News articles 0
Drug details — simvastatin
US status
approved
Class
Route
ORAL
Patents
6
Programs
14
Data quality
0.89

Quick answer

simvastatin (APO-SIMVASTATIN) is a hmg-coa reductase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN simvastatin
Brand APO-SIMVASTATIN
Mechanism HMG-CoA reductase inhibitor
Target 3-hydroxy-3-methylglutaryl-coenzyme A reductase
Route ORAL
Formulation TABLET, ORALLY DISINTEGRATING

Mechanism of action

HMG-CoA reductase inhibitor

Primary target: 3-hydroxy-3-methylglutaryl-coenzyme A reductase

Approval history

Authority Status Date
FDA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. Lapaquistat acetate and simvastatin Phase 3 · Takeda · Hypercholesterolemia
  2. R727-CL-1112 Phase 3 · Regeneron UK · Heterozygous Familial Hypercholesterolemia
  3. SATURN Phase 3 · George Institute for · Spontaneous lobar ICH
  4. SIMFIB Phase 3 · George Institute for · Fibrosis liber, chronic liver disease, alcoholic liver disea
  5. Gemcitabine+simvastatin Phase 2 · Samsung Bioepis · Pancreatic Cancer
  6. OPDIVO for advanced or metastatic gastrooe… Phase 2 · Telethon Foundation · advanced or metastatic gastrooesophageal carcinoma HER2 nega
  7. VESPA Phase 2 · Telethon Foundation · Metastatic pancreatic ductal adenocarcinoma (mPDAC)
  8. Simvastatin Phase 1 · United Therapeutics Europe · Recurrent Acute Pancreatitis

Related & competitor drugs

  1. atorvastatin calcium HMG-CoA reductase inhibitor
  2. fluvastatin sodium HMG-CoA reductase inhibitor
  3. lovastatin HMG-CoA reductase inhibitor
  4. pitavastatin calcium HMG-CoA reductase inhibitor
  5. rosuvastatin calcium HMG-CoA reductase inhibitor
  6. cerivastatin sodium HMG-CoA reductase inhibitor
  1. US 11197844

    Triple drug combination (metformin, simvastatin, digoxin) for targeted treatment of pancreatic cancer

    Expires Mon Dec 09 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 10813909

    Triple drug combination (metformin, simvastatin, digoxin) for targeted treatment of pancreatic cancer

    Expires Mon Oct 22 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 10793884

    Methods and materials for making simvastatin and related compounds

    Expires Mon Oct 01 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 9970037

    Methods and materials for making simvastatin and related compounds

    Expires Mon May 10 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 8951754

    Methods and materials for making simvastatin and related compounds

    Expires Mon Feb 05 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 8211664

    Methods and materials for making simvastatin and related compounds

    Expires Mon Jun 28 2032 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is simvastatin?

simvastatin (APO-SIMVASTATIN) is a hmg-coa reductase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for simvastatin?

APO-SIMVASTATIN is a marketed brand name for simvastatin. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of simvastatin?

simvastatin has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.