Drug

Simvastatin

Regulatory activity · MHRA

ClassHMG-CoA reductase inhibitorEmerging researchLate-stage developmentRising momentum

Also known as Flolipid, Juvisync, Simcor, Vytorin+6 more

Flolipid, Juvisync, Simcor, Vytorin, Zocor, Ezetimibe-Simvastatin, Simvastatina, Simvastatine, 2,2-dimethylbutyric acid, 8-ester with (4R,6R)-6-(2-((1S,2S,6R,8S,8aR)-1,2,6,7,8,8a-hexahydro-8-hydroxy-2,6-dimethyl-1-naphthyl)ethyl)tetrahydro-4-hydroxy-2H-pyran-2-one, Simvastatinum.

RxNorm36567 ChEMBLCHEMBL1064 ATCC10AA01UNIIAGG2FN16EV

Research papers

Active clinical trials

HMGCR

Primary target

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Double-blinded, Phase II, Randomized Control Trial to Study the Effects of Simvastatin in Patients With Uterine Leiomyoma

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

RESTAGE (REpurposing STAtins to Improve Outcomes in GastroEsophageal Cancer) Trial: A Phase II Randomized Open-Label Trial of Perioperative Simvastatin Plus Standard-of-Care Systemic Therapy in Gastroesophageal Adenocarcinoma

Clinical trial2026-07-10Results expected Q2 2029 · ClinicalTrials.gov

A Drug-Drug Interaction Study to Assess the Effect of Orforglipron on the Pharmacokinetics of Digoxin, Simvastatin, Rosuvastatin, Acetaminophen, and Midazolam in Healthy Overweight and Obese Participants

Clinical trial2026-05-22Results posted · ClinicalTrials.gov

A Phase III, Multicentre, Double-blind, Double-dummy, Randomised, Flexible-dose, Comparative Study of MCI-196 Versus Simvastatin for the Treatment of Dyslipidaemia in Subjects With Chronic Kidney Disease on Dialysis (Incorporating a Placebo-controlled Withdrawal Phase)

Clinical trial2026-01-07Results posted · ClinicalTrials.gov

Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis

Clinical trial2025-12-31Primary completion · ClinicalTrials.gov

Effect of high-dose simvastatin on cognitive, neuropsychiatric, and health-related quality-of-life measures in secondary progressive multiple sclerosis: secondary analyses from the MS-STAT randomised, placebo-controlled trial.

Research2017-06-07The Lancet. Neurology

Achievement of dual low-density lipoprotein cholesterol and high-sensitivity C-reactive protein targets more frequent with the addition of ezetimibe to simvastatin and associated with better outcomes in IMPROVE-IT.

Research2015-09-01Circulation

Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes.

Research2015-06-03The New England journal of medicine

Drug Safety Update: Simvastatin: dose limitations with concomitant amlodipine or diltiazem

Regulatory2014-12-11MHRA

Drug Safety Update: Simvastatin: increased risk of myopathy at high dose (80 mg)

Regulatory2014-12-11MHRA

Drug Safety Update: Simvastatin: updated advice on drug interactions

Regulatory2014-12-11MHRA

Effect of high-dose simvastatin on brain atrophy and disability in secondary progressive multiple sclerosis (MS-STAT): a randomised, placebo-controlled, phase 2 trial.

Research2014-03-19Lancet (London, England)

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Simvastatin

Aliases & brands

FlolipidJuvisyncSimcorVytorinZocorEzetimibe-SimvastatinSimvastatinaSimvastatine2,2-dimethylbutyric acid, 8-ester with (4R,6R)-6-(2-((1S,2S,6R,8S,8aR)-1,2,6,7,8,8a-hexahydro-8-hydroxy-2,6-dimethyl-1-naphthyl)ethyl)tetrahydro-4-hydroxy-2H-pyran-2-oneSimvastatinum

RxNorm CUI

36567

ChEMBL ID

CHEMBL1064

ATC codes

C10AA01

UNII

AGG2FN16EV

Primary mechanism

HMG-CoA reductase inhibitor

Regulatory jurisdictions

mhra

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

3-hydroxy-3-methylglutaryl-coenzyme A reductase

HMGCR · P04035

INHIBITORHMG-CoA reductase inhibitor

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities

MHRA

Total events

mhraMedicines and Healthcare products Regulatory Agency· 3 events

2014-12-11Safety communicationSafety

Drug Safety Update: Simvastatin: dose limitations with concomitant amlodipine or diltiazem

Evidence ↗

2014-12-11Safety communicationSafety

Drug Safety Update: Simvastatin: updated advice on drug interactions

Evidence ↗

2014-12-11Safety communicationSafety

Drug Safety Update: Simvastatin: increased risk of myopathy at high dose (80 mg)

Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

191 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

191

registered trials across all phases

LATEST COMPLETION 2024

Active studies

Recruiting

113

Late-stage (III+)

136

Completed

Discontinued

PHASE DISTRIBUTIONn = 191

Early Phase 15Phase 141Phase 1 / 23Phase 229Phase 2 / 35Phase 340Phase 445Phase N / A23

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis

RecruitingPH IVPenn State Universityn=282026

Impact of Roux-en-Y Gastric Bypass (RYGB) Bariatric Surgery on System Pharmacology: Single-dose Cross-over Pharmacokinetic Study of Simvastatin and Carvedilol.

Unknown statusPH IVNatalia Valadares de Moraesn=1202023

Effect of Simvastatin on Sepsis and Febrile Neutropenia in Patients With Acute Lymphoblastic Leukemia

Unknown statusPH IVHospital General de Mexicon=1082023

Effect of Statin Therapy on Mortality in Patients With Ventilator Associated Pneumonia

CompletedPH IVAin Shams Universityn=1612022

7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin

TerminatedPH IVUniversity of Texas Southwestern Medical Centern=32021

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3 Randomised, Double Blind, Clinical Trial Investigating the Effectiveness of Repurposed Simvastatin Compared to Placebo, in Secondary Progressive Multiple Sclerosis, in Slowing the Progression of Disability

CompletedPH IIIUniversity College, Londonn=9642024

CompletedPH IEli Lilly and Companyn=502024

A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of AZD9291 on the Pharmacokinetics of Simvastatin (a Sensitive CYP3A4 Substrate) in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI

CompletedPH IAstraZenecan=522024

A Double-blind, Randomised, Placebo-controlled Single-site Study of High Dose Simvastatin Treatment for Secondary Progressive Multiple Sclerosis: Impact on Vascular Perfusion and Oxidative Damage

CompletedPH IIUniversity College, Londonn=402023

Treatment With HMG-COA Reductase Inhibitor (Simvastatin) of Growth and Bone Abnormalities in Children With Noonan Syndrome: A Phase III Randomised, Double Blind, Placebo-controlled Therapeutic Trial

CompletedPH IIIUniversity Hospital, Toulousen=532023

The Effect of 28-day Simvastatin Administration on Emotional Processing, Reward Learning, Working Memory, and Salivary Cortisol in Healthy Volunteers At-risk for Depression

CompletedN/AUniversity of Oxfordn=1012023

Research activity

8 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20102017

Most influential

Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes.

The New England journal of medicine · 2015 · 3,026 cites

Effect of high-dose simvastatin on brain atrophy and disability in secondary progressive multiple sclerosis (MS-STAT): a randomised, placebo-controlled, phase 2 trial.

Lancet (London, England) · 2014 · 322 cites

Circulation · 2015 · 251 cites

mTORC2 is required for proliferation and survival of TSC2-null cells.

Molecular and cellular biology · 2011 · 105 cites

Simvastatin as a treatment for pulmonary hypertension trial.

American journal of respiratory and critical care medicine · 2010 · 96 cites

The Lancet. Neurology · 2017 · 88 cites

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Ezetimibe

Studied across 2 of the same disease areas as Simvastatin in the shared literature.

2 shared diseases1 shared paper

Triglycerides

Studied across 2 of the same disease areas as Simvastatin in the shared literature.

2 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.