Simvastatin for multiple sclerosis
Last updated Aug. 26, 2025, by Marisa Wexler, MS
Fact-checked by Inês Martins, PhD
What is simvastatin for MS?
Simvastatin is an oral therapy that was studied as a potential treatment for certain forms of multiple sclerosis (MS), namely relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS), but which failed to demonstrate definitive signs of efficacy in larger clinical trials.
In trials, the therapy was administered once daily in the form of oral tablets. It proved no better than a placebo, however, at slowing disability progression. Due to these disappointing results, it is unlikely that simvastatin will continue to be tested as a possible treatment for MS.
The compound belongs to a group of drugs called statins, which are widely approved to lower cholesterol levels and reduce the risk of cardiovascular problems. Statins, however, also reduce inflammation and are thought to promote recovery and regeneration of nerve cells. Those effects led to the investigation of simvastatin as a potential multiple sclerosis (MS) therapy.
Simvastatin was initially marketed by Merck under the brand name Zocor, but other brand names and multiple generic versions are now widely available.
Therapy snapshot
| Treatment name: | Simvastatin |
| Administration: | Oral tablets |
| Clinical testing: | Development status is unknown after large trials showed negative results. |
Simvastatin in MS clinical trials
Simvastatin was first tested either on its own or in combination with Avonex (interferon beta-1a) in people with RRMS. While an initial clinical trial showed a significant reduction in the number and volume of brain lesions with simvastatin after six months, subsequent combination trials (NCT00668343 and (NCT00492765) yielded conflicting results, failing to meet most or all of their clinical outcomes.
The therapy then was tested in people with SPMS in two clinical trials led by researchers at Imperial College London in the U.K. Participants in these trials received either a placebo or simvastatin at a dose of 40 mg over the first month and 80 mg thereafter.
- The MS-STAT Phase 2 trial (NCT00647348) enrolled 140 people with SPMS. After two years of treatment, participants given simvastatin showed significantly less brain volume loss, or atrophy, had lower disability scores, and reported less physical impact of their MS than those given a placebo. These benefits were independent of the medicine’s effect on cholesterol levels.
- Based on those promising findings, researchers launched a Phase 3 study called MS-STAT2 (NCT03387670), which tested three years of simvastatin treatment in 964 adults with SPMS, followed by an extension portion. The study hoped to confirm that simvastatin could reduce the risk of sustained disability progression, but its results were negative — about 40% of patients in both groups experienced confirmed progression over four years.
The treatment was generally safe and well tolerated in these two trials. Most side effects were mild in severity and occurred at similar frequencies in the simvastatin and placebo groups.
Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
FAQs about simvastatin in MS
Simvastatin is a cholesterol-lowering agent that is believed to reduce inflammation and protect nerve cells from damage, which was expected to help treat multiple sclerosis (MS). However, clinical trials involving people with relapsing-remitting MS and secondary progressive MS have generally yielded negative results, so it’s not known if simvastatin will be further tested in any of these indications.
Clinical trials testing simvastatin in people with multiple sclerosis (MS) have produced either mixed or negative results, failing to meet many of their primary and secondary goals. For this reason, it is unlikely that simvastatin will continue to be developed for MS or approved by the U.S. Food and Drug Administration.
Based on its prescribing information for other indications, simvastatin may cause fetal harm and should be discontinued during pregnancy. Patients should talk with their healthcare team if they become pregnant or plan to become pregnant while on this medication.
In a small clinical trial involving people with relapsing-remitting multiple sclerosis, a significant reduction in brain lesions became evident after six months of treatment. Still, as each person is unique, patients should always ask their doctor how a medication might affect them.
Weight gain and hair loss were not reported as side effects of simvastatin in multiple sclerosis clinical trials. However, some people who received the medication for other indications have experienced hair loss. Patients experiencing unexpected reactions to medication should talk with their healthcare provider.
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