Data updated: May 26, 2026
JUVISYNC (simvastatin)
Metabolic
Approved 2011-10-07
2
Indications
--
Phase 3 Trials
14
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2011-10-07
- Patent Cliff
- 2026
- Routes
- ORAL
- Dosage Forms
- TABLET
JUVISYNC Approval History
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
66 FDA actions from 2011 to 2014 · 1 indication expansions
Nov 2013 SUPPL
Mfg · Manufacturing (CMC)
What JUVISYNC Treats
2 FDA approvalsOriginally approved for its first indication in 2011 . Covers 2 distinct patient populations.
- Other (2)
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Clinical Trial Registry
140 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02968810 results posted | NCI-2016-01719 NCI-2016-01719, N01-CN-2012-00035 | Ph 2 | active not recruiting | Simvastatin in Preventing Liver Cancer in Patients With Liver Cirrhosis |
| NCT00858637 results posted | MCI-196-E11 | Ph 3 | completed | Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis |
| NCT02675309 | MT-8554-E05 | Ph 1 | completed | A Study to Investigate the Effect of MT-8554 on the Pharmacokinetics of Simvastatin and Rosuvastatin in Healthy Subjects |
| NCT02197234 results posted | D5160C00014 2014-002070-36 | Ph 1 | completed | Study to Assess the Effect of AZD9291 on the Blood Levels of Simvastatin in Patients With EGFRm+ NSCLC |
| NCT03889795 | C3 | Ph 1 | active not recruiting | Phase IB Metformin, Digoxin, Simvastatin in Solid Tumors |
| NCT06948747 | D7260C00017 | Ph 1 | completed | A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of Erythromycin on AZD5004 in Healthy Participants |
| NCT03896217 MS-OPT results posted | 16/0730 & 2017-003008-30 | Ph 2 | completed | Simvastatin in Secondary Progressive Multiple Sclerosis |
| NCT01602029 ROSES | roses_pill | Ph 2 | completed | Randomized Double Blind Placebo Control Study in Patients with Schizophrenia |
| NCT03387670 MS-STAT2 | 17/0158 2017-003328-56 | Ph 3 | completed | Multiple Sclerosis-Simvastatin Trial 2 |
| NCT06186622 | 18631 J2A-MC-GZPG | Ph 1 | completed | A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants |
| NCT02735707 REMAP-CAP | U1111-1189-1653 2015-002340-14, 602525 | Ph 3 | recruiting | Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia |
| NCT02096588 results posted | J13160 J13160, NA_00091900 | Ph 2 | terminated | Detection and Prevention of Anthracycline-Related Cardiac Toxicity With Concurrent Simvastatin |
| NCT06399783 | Sim vs Cs | Ph 4 | not yet recruiting | Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata |
| NCT06207682 | CL020_168 | Ph 1 | completed | Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics (PK) of a Single Dose of Simvastatin |
| NCT06016218 | 260981 | Ph 1, Ph 2 | completed | Effect of Local Application of Simvastatin Versus Bone Powder on Implant Bone Changes |
| NCT03454529 results posted | 2017-073 NCI-2018-00044, 2017-073 | Ph 2 | completed | The Effect of Simvastatin on Breast Cancer Cell Growth in Women With Stage I-II Breast Cancer |
| NCT05542095 SimCA | SimCA Trial | Ph 1 | withdrawn | Simvastatin Nasal Rinses for the Treatment of COVID-19 Mediated Dysomsia |
| NCT03780673 2018-001698-25 | LIVERHOPE_EFFICACY | Ph 2, Ph 3 | completed | Efficacy of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis to Prevent ACLF Development |
| NCT02713945 RASTAT | RC31/15/7826 | Ph 3 | completed | Treatment With HMG-COA Reductase Inhibitor of Growth and Bone Abnormalities in Children With Noonan Syndrome |
| NCT03510884 results posted | EFC14643 2017-001903-60, U1111-1193-0721 | Ph 3 | completed | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia |
| NCT00655993 | 00746 | Ph 1 | completed | Effect of Statin Therapy on C-reactive Protein Levels in Patients With Chronic Obstructive Lung Disease (COPD) |
| NCT02188121 FITNESS results posted | 2014P001599 | Ph 4 | completed | Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients |
| NCT05580250 | 18353 J2D-JE-CVAD | Ph 1 | withdrawn | A Study of LY3526318 in Healthy Male Japanese Participants |
| NCT05657015 | Local drug delivery | Ph 4 | completed | Lepidium Sativum Extract Versus Simvastatin as an Adjunctive Local Delivery Agents to Non-Surgical Periodontal Therapy |
| NCT02743364 results posted | NCI-2016-00437 NCI-2016-00437, N01-CN-2012-00035 | Ph 2 | completed | Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis |
| NCT01763866 LAPLACE-2 results posted | 20110115 2012-001363-70 | Ph 3 | completed | LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2 |
| NCT02871687 | 2016P000094 | Ph 1 | completed | Effect of Statin Use on Aldosterone Secretion |
| NCT02542969 | MGL-3196-03 | Ph 1 | completed | Drug Interaction Study of MGL-3196 With Rosuvastatin and Simvastatin |
| NCT03775070 SavDCM | 201806014MINB | Ph 2 | completed | Simvastatin Therapy in Patients With Dilated Cardiomyopathy. |
| NCT05306379 Statin-DDI | AUR-VCS-2021-02 | Ph 1 | completed | Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin |
| NCT01156545 | NCCCTS-10-489 BIBW 2992 1200.113 | Ph 2 | completed | BIBW 2992 Plus Simvastatin vs. BIBW 2992 in Previously Treated Patients With Advanced Non-adenocarcinomatous NSCLC |
| NCT02476006 results posted | LPS14245 2015-000620-28, U1111-1163-0984 | Ph 3 | completed | Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE) |
| NCT05230472 | EMASU M D 219 /2020 | Ph 4 | completed | Effect of Statin Therapy on Mortality in Patients With Ventilator Associated Pneumonia |
| NCT01952288 results posted | B1195-I | Ph 4 | completed | Simvastatin for mTBI |
| NCT02787590 PD STAT | PDSTAT2015 2015-000148-40, 16108482 | Ph 2 | completed | Simvastatin as a Neuroprotective Treatment for Moderate Parkinson's Disease |
| NCT05008068 | 0012490 | Ph 1 | completed | Effect of Local Application of Platelet-rich Fibrin Scaffold Loaded With Simvastatin on Peri-implant Bone Changes |
| NCT01979185 results posted | SPD602-114 | Ph 1 | completed | Effect of SSP-004184 (SPD602) on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects |
| NCT01953835 | 117171 | Ph 1 | completed | A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184 |
| NCT02714569 results posted | 16417 I8Q-MC-GSEA | Ph 1 | completed | A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia |
| NCT04803500 | PER 15-1M | Ph 2 | completed | Simvastatin Around Immediate Implant |
| NCT03510715 results posted | EFC14660 2017-002297-39, U1111-1200-2046 | Ph 3 | completed | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia |
| NCT04343001 CRASH-19 | 2020-KEP-420 | Ph 3 | withdrawn | Coronavirus Response - Active Support for Hospitalised Covid-19 Patients |
| NCT03929744 | 17416 J2A-MC-GZGA | Ph 1 | completed | A Study of LY3502970 in Healthy Participants |
| NCT01382472 MICROS | MICROS | Ph 4 | completed | Microcirculation In Acute Coronary Syndromes |
| NCT01999309 | 43806 | Ph 3 | completed | Simvastatin Addition for Patients With Recent-onset Schizophrenia |
| NCT02061397 SOS results posted | The SOS Trial | Ph 1, Ph 2 | completed | Safety of Simvastatin in LAM and TSC |
| NCT02300259 results posted | 15523 I7T-MC-RMAG | Ph 1 | completed | A Study of LY2623091 in Healthy Participants |
| NCT02399709 ADDICSTATINE | ADDICSTATINE | Ph 2 | completed | Trial to Evaluate the Efficacy of Simvastatin for Smoking Cessation |
| NCT02390843 AflacST1402 | IRB00078790 | Ph 1 | completed | Simvastatin With Topotecan and Cyclophosphamide in Relapsed and/or Refractory Pediatric Solid and CNS Tumors |
| NCT02533141 | OPHT-240215 | Ph 4 | withdrawn | Effect of Simvastatin Withdrawal on Ocular Endothelial Function |
Showing 50 of 140 trials
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
JUVISYNC FDA Label Details
View full patent landscape →
2 OB patents · 1 families ·
67 international docs across 41 countries
JUVISYNC Patents & Exclusivity
Latest Patent: Oct 2026
Patents (2 active)
US7326708*PED
Expires Oct 11, 2026
US7326708
Expires Apr 11, 2026
Source: FDA Orange Book
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Revenue Insights
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Patent Timeline
- • Cliff: 2026
- • 72 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.