When Will Mounjaro Be Approved for Weight Loss?
Mounjaro, a medication initially developed for type 2 diabetes, has gained attention for its weight loss benefits. Many people are eager to know when Mounjaro will be approved for weight loss. This article explores its journey, effectiveness, and what to expect in simple terms.
What Is Mounjaro?
Mounjaro is a brand name for tirzepatide, a drug made by Eli Lilly. It was approved by the FDA in May 2022 to manage type 2 diabetes. The drug is given as a weekly injection and helps control blood sugar levels.
Tirzepatide works by mimicking two hormones: GLP-1 and GIP. These hormones regulate blood sugar and appetite, which can lead to weight loss. This dual action makes Mounjaro unique compared to other diabetes drugs.
Why Is Mounjaro Linked to Weight Loss?
Clinical trials showed that Mounjaro users lost significant weight, even if they didn’t have diabetes. This sparked interest in its potential as a weight loss drug. The drug reduces appetite and slows digestion, helping people feel full longer.
In studies, participants lost up to 20-25% of their body weight over 72 weeks. These results were remarkable compared to other weight loss medications. This led to excitement about when Mounjaro will be approved for weight loss.
Current FDA Approval Status
Mounjaro is not yet FDA-approved for weight loss as of April 2025. However, its active ingredient, tirzepatide, is approved for weight loss under a different brand name, Zepbound. The FDA approved Zepbound in November 2023 for chronic weight management.
Zepbound is used for adults with obesity (BMI of 30 or higher) or those overweight (BMI of 27 or higher) with health issues like high blood pressure. Since Mounjaro and Zepbound share the same active ingredient, many wonder why Mounjaro itself isn’t approved for weight loss.
The Fast-Track Process for Weight Loss Approval
In October 2022, the FDA granted Mounjaro a “fast-track” designation for weight loss. This means the FDA is reviewing it quickly due to its potential to treat obesity, a serious condition. Fast-track status speeds up the approval process.
Eli Lilly submitted data from trials like SURMOUNT-1 and SURMOUNT-2. These showed significant weight loss in participants. The question of when Mounjaro will be approved for weight loss depends on the FDA’s review timeline.
Why Zepbound Instead of Mounjaro?
Eli Lilly chose to market tirzepatide for weight loss as Zepbound, not Mounjaro. This is likely due to branding and marketing strategies. Mounjaro is positioned for diabetes, while Zepbound targets weight loss.
Both drugs have the same active ingredient and similar dosing. However, Zepbound’s approval for weight loss makes it more accessible for that purpose. Insurance may cover Zepbound for weight loss but not Mounjaro, which is often prescribed off-label.
Off-Label Use for Weight Loss
Doctors can prescribe Mounjaro off-label for weight loss, even without FDA approval for that use. Off-label means using a drug for a purpose other than its approved one. Many patients have used Mounjaro this way with success.
However, off-label use can be costly. Insurance may not cover Mounjaro for weight loss, leaving patients to pay over $1,000 a month. Zepbound may be a more affordable option for those seeking weight loss treatment.
Clinical Trial Results
The SURMOUNT trials provided strong evidence for Mounjaro’s weight loss potential. In SURMOUNT-1, participants without diabetes lost up to 22.5% of their body weight. Those on the highest dose (15 mg) saw the best results.
SURMOUNT-2 focused on people with type 2 diabetes and obesity. They lost up to 15.7% of their body weight. These results highlight why many are asking when Mounjaro will be approved for weight loss.
How Does Mounjaro Compare to Other Drugs?
Mounjaro is often compared to drugs like Ozempic and Wegovy, which contain semaglutide. Both drugs reduce appetite, but Mounjaro’s dual action (GLP-1 and GIP) may lead to greater weight loss. Studies suggest Mounjaro users lose more weight than those on Ozempic.
Here’s a quick comparison:
| Drug | Active Ingredient | Approved Use | Average Weight Loss |
|---|---|---|---|
| Mounjaro | Tirzepatide | Type 2 diabetes | 20-25% (off-label) |
| Zepbound | Tirzepatide | Weight loss | 20-25% |
| Wegovy | Semaglutide | Weight loss | 15% |
| Ozempic | Semaglutide | Type 2 diabetes | 8-12% (off-label) |
This table shows Mounjaro and Zepbound outperform others in weight loss.
Benefits of Mounjaro for Weight Loss
Mounjaro offers several benefits beyond weight loss. It improves blood sugar control, which is helpful for those with diabetes or prediabetes. It also lowers blood pressure and cholesterol levels.
Users report feeling less hungry and more satisfied with smaller meals. These effects make it easier to stick to a healthy diet. The weekly injection is also convenient compared to daily pills.
Potential Side Effects
Like all medications, Mounjaro has side effects. The most common are stomach-related, such as nausea, diarrhea, and decreased appetite. These often improve over time.
Serious side effects are rare but include pancreatitis and kidney issues. Mounjaro has a boxed warning for a possible risk of thyroid tumors. Patients should discuss risks with their doctor.
Who Can Use Mounjaro for Weight Loss?
Mounjaro (or Zepbound) is best for adults with obesity or those overweight with health conditions. It’s not suitable for everyone, including those with type 1 diabetes or certain medical conditions. A doctor will assess if it’s safe for you.
Lifestyle changes are key. Mounjaro works best with a healthy diet and regular exercise. Without these, weight loss may be less effective, and weight can return if the drug is stopped.
Cost and Accessibility
Mounjaro’s cost is a barrier for many. Without insurance, it can cost $1,000-$1,200 per month in the U.S. Eli Lilly offers a savings card, reducing it to as low as $25 for some with commercial insurance.
In India, Mounjaro launched in March 2025, priced at $40-$50 for lower doses. This is more affordable but still expensive for long-term use. Zepbound may be covered by insurance for weight loss, unlike Mounjaro.
Global Availability
Mounjaro is available in countries like the U.S., UK, Europe, and India. In the UK, it’s approved for both diabetes and weight loss (as Mounjaro, not Zepbound). The NHS limits access to those with high BMI and health issues.
In India, its launch has increased demand for weight loss treatments. Clinics report a surge in inquiries, showing growing awareness of obesity as a health issue.
What to Expect in 2025
As of April 2025, Mounjaro is unlikely to gain FDA approval for weight loss soon. Zepbound already fills that role, and Eli Lilly seems focused on promoting it. However, off-label use of Mounjaro will likely continue.
More studies are exploring Mounjaro’s long-term effects. These could influence future approvals or guidelines. For now, patients interested in weight loss should ask their doctor about Zepbound.
Tips for Using Mounjaro Safely
If prescribed Mounjaro, follow these tips:
- Start with a low dose (2.5 mg) to reduce side effects.
- Inject weekly on the same day, in the abdomen, thigh, or upper arm.
- Pair with a balanced diet and exercise for best results.
- Report side effects to your doctor immediately.
Always use Mounjaro under medical supervision. Never adjust doses without consulting your doctor.
Summary
Mounjaro, or tirzepatide, is a promising drug for weight loss, but it’s not FDA-approved for that use as of April 2025. Its sister drug, Zepbound, is approved for weight loss, offering the same benefits. Mounjaro’s impressive trial results, with up to 25% weight loss, make it a popular off-label choice. However, costs and side effects are considerations. With lifestyle changes, Mounjaro or Zepbound can be effective for managing weight and health.
FAQ
When will Mounjaro be approved for weight loss?
Mounjaro is not FDA-approved for weight loss as of April 2025. Zepbound, with the same ingredient, is approved for weight loss. Eli Lilly may not pursue Mounjaro approval for this use soon.
How much weight can you lose with Mounjaro?
Clinical trials show 20-25% weight loss over 72 weeks. Results vary based on dose, diet, and exercise. Higher doses (15 mg) yield the most weight loss.
Is Mounjaro safe for weight loss?
Mounjaro is safe for many but has side effects like nausea and diarrhea. Serious risks include pancreatitis. Consult your doctor to ensure it’s safe for you.
How does Mounjaro compare to Wegovy?
Mounjaro (tirzepatide) may lead to more weight loss than Wegovy (semaglutide), up to 25% vs. 15%. Both reduce appetite, but Mounjaro targets two hormones.
How much does Mounjaro cost?
Mounjaro costs $1,000-$1,200 monthly without insurance in the U.S. Savings cards can lower it to $25 for some. In India, it’s $40-$50 per dose.