Retatrutide Approval Tracker: FDA, EMA, TGA Status (2025)

Retatrutide is one of the most anticipated weight-loss drugs in history, often nicknamed the "triple G" because of how it targets three different hormone receptors at once. However, as of late 2025, it is not yet approved by the FDA (United States), EMA (Europe), or TGA (Australia).

Currently, the drug is in the final and most critical stage of development: Phase 3 clinical trials. This article serves as a comprehensive tracker for patients, researchers, and investors who want to know exactly where retatrutide stands in the regulatory pipeline and when it might finally reach pharmacies.

Current Global Status at a Glance

Before diving into the details, here is the high-level status of retatrutide across major global regulatory agencies.

Region	Regulatory Agency	Current Status	Predicted Submission	Predicted Approval
United States	FDA	Phase 3 Clinical Trials	Late 2025 / Early 2026	2026–2027
European Union	EMA	Phase 3 Clinical Trials	2026	2026–2027
United Kingdom	MHRA	Phase 3 Clinical Trials	2026	2026–2027
Australia	TGA	Phase 3 Clinical Trials	2026	2027
Canada	Health Canada	Phase 3 Clinical Trials	2026	2027

As you can see, the timeline is consistent across most Western nations. This is because Eli Lilly, the manufacturer, typically submits data to major agencies (FDA and EMA) around the same time.

The Road to Approval: Understanding the Process

To understand why retatrutide isn't available yet—and why it takes so long—it helps to understand the rigorous journey a drug must take before a doctor can prescribe it.

Phase 1: Is it Safe? (Completed)

In this early stage, the drug is given to a very small group of healthy volunteers. The goal isn't to see if it works for weight loss, but simply to make sure it doesn't cause immediate, dangerous harm. Retatrutide passed this phase years ago.

Phase 2: Does it Work? (Completed in 2023)

This is the phase that made headlines. In Phase 2, researchers gave retatrutide to a few hundred people with obesity. The results were stunning: participants lost up to 24.2% of their body weight in 48 weeks. This data was published in the New England Journal of Medicine and is the main reason there is so much excitement today. However, Phase 2 trials are too small to catch rare side effects.

Phase 3: The "Gold Standard" (In Progress Now)

This is where retatrutide is today. Phase 3 trials are massive. They involve thousands of patients across many countries and last for longer periods (often a year or more). The goal is to prove that the Phase 2 results weren't a fluke and to ensure the drug is safe for a diverse population—people with heart disease, kidney issues, different ethnic backgrounds, and various ages.

NDA Submission & Review (The Next Step)

Once Phase 3 is done, Eli Lilly will collect millions of pages of data and submit a New Drug Application (NDA) to the FDA. The FDA then has 6 to 10 months to review every single detail. Only after they sign off can the drug be sold.

Deep Dive: The TRIUMPH Clinical Trial Program

Eli Lilly's Phase 3 program for retatrutide is called TRIUMPH. It consists of several distinct trials, each asking a different question. The completion of these trials is the primary factor determining when retatrutide will be approved.

TRIUMPH-1: Obesity Without Diabetes

Identifier: NCT05882045
Goal: To see how much weight people lose who are obese or overweight but do not have Type 2 Diabetes.
Why it matters: This will likely be the primary study used to ask for "weight loss" approval. Drugs often work better in people without diabetes, so the weight loss numbers here are expected to be the highest.
Participants: Approximately 2,000 people.
Status: Ongoing.

TRIUMPH-2: Obesity With Type 2 Diabetes

Identifier: NCT05897219
Goal: To test weight loss specifically in people who do have Type 2 Diabetes.
Why it matters: People with diabetes typically find it harder to lose weight. This study will show doctors what results to expect for diabetic patients. It also tracks how well retatrutide lowers blood sugar (A1C).
Participants: Approximately 1,000 people.
Status: Ongoing.

TRIUMPH-3: Cardiovascular Outcomes

Identifier: NCT06065515
Goal: To see if retatrutide prevents heart attacks, strokes, and cardiovascular death in people with obesity and heart disease.
Why it matters: This is huge. If retatrutide can prove it saves lives—not just lowers weight—insurance companies will be much more likely to cover it.
Status: Ongoing.

TRIUMPH-4: Knee Osteoarthritis

Identifier: NCT06037084
Goal: To see if losing weight with retatrutide helps reduce knee pain and improve function in people with osteoarthritis.
Why it matters: This targets a specific quality-of-life improvement that affects millions of older adults.
Status: Ongoing.

FDA Approval Status (USA) Details

What is the FDA looking for?

For the FDA to approve retatrutide, they need to see that the benefits outweigh the risks.

Benefits: They want to see weight loss of at least 5% (retatrutide is expected to far exceed this).
Risks: They are watching closely for side effects like nausea, vomiting, and heart rate increases. In Phase 2, retatrutide was shown to increase heart rate slightly more than other drugs, so the FDA will scrutinize the Phase 3 heart safety data very carefully.

Fast Track Designation

The FDA has programs to speed up drugs that treat serious conditions. Obesity is increasingly recognized as a serious disease. While specific regulatory designations are confidential until announced, given the sheer effectiveness seen in Phase 2, retatrutide is a prime candidate for "Priority Review," which could shorten the FDA's decision time from 10 months to 6 months once the application is submitted.

EMA Approval Status (Europe) Details

The European Medicines Agency (EMA) handles approvals for the European Union. Their process is similar to the FDA's but has some key differences.

Assessment: The EMA's Committee for Medicinal Products for Human Use (CHMP) conducts the scientific assessment.
Decision: Once the CHMP gives a positive opinion, the European Commission makes the final legally binding decision about two months later.
Launch: Even after approval, each individual country (like France, Germany, or Italy) must negotiate pricing with Eli Lilly before the drug appears in pharmacies. This means patients in Germany might get it months before patients in Spain.

TGA Approval Status (Australia) Details

In Australia, the Therapeutic Goods Administration (TGA) assesses new drugs.

The Process: The TGA often participates in "work-sharing" programs with other agencies like Health Canada or the MHRA (UK) to speed up reviews.
PBS Listing: Getting "approved" is only step one. Step two is getting listed on the Pharmaceutical Benefits Scheme (PBS), which subsidizes the cost. Without a PBS listing, the drug could cost patients hundreds of dollars a month out-of-pocket. PBS listing usually happens significantly later than TGA approval.

Comparisons: Retatrutide vs. Mounjaro vs. Wegovy

Looking at history helps us predict the future. Here is how long it took other blockbuster weight-loss drugs to go from trial to approval.

Mounjaro (Tirzepatide)

Timeline: Phase 3 results came out in mid-2021. FDA approval for diabetes came in May 2022. FDA approval for weight loss (branded as Zepbound) came in November 2023.
Lesson: There can be a gap between approval for diabetes and approval for weight loss, even if it's the exact same drug.

Wegovy (Semaglutide)

Timeline: Phase 3 results were published in early 2021. FDA approval came in June 2021.
Lesson: When the data is overwhelmingly positive, the FDA can move relatively quickly.

What Could Cause Delays?

While 2026–2027 is the best estimate, several things could push this date back:

Safety Signals: If the Phase 3 trials show an unexpected side effect (like severe heart rhythm issues or liver problems), the FDA could ask for more studies.
Manufacturing Issues: Retatrutide is a complex biological molecule. Eli Lilly has struggled to make enough Mounjaro/Zepbound to meet demand. If they can't build enough factories to make retatrutide, they might delay the launch.
Data Analysis: Analyzing data from 5,000+ participants takes time. If the data is messy or incomplete, cleaning it up adds months to the timeline.

FAQs

Is retatrutide FDA approved right now? No. As of late 2025, it is an investigational new drug.

Can I get retatrutide under "Compassionate Use"? Compassionate use (Expanded Access) is usually reserved for life-threatening conditions where no other treatment exists. Since other weight loss drugs (Wegovy, Zepbound) are available, it is unlikely that a doctor would be granted compassionate use access for retatrutide for standard obesity.

Does the "Research Chemical" label mean it's legal? The label "Research Chemical" is a marketing tactic used by online vendors to sell unapproved substances. It does not make the drug FDA-approved or safe for human use.

Will retatrutide be cheaper than Zepbound? Pricing is unknown, but newer, more effective drugs typically launch at a premium or at price parity with existing premium options. Do not expect it to be a low-cost generic.

Conclusion

The approval of retatrutide is a question of "when," not "if," assuming the Phase 3 safety data holds up. The efficacy seen in early trials suggests it could be the most powerful weight-loss medication ever created.

However, patience is required. The regulatory process is designed to protect the public from unforeseen risks. Until the FDA, EMA, and TGA give the green light—likely in 2026 or 2027—the only safe and legal way to access retatrutide is through a clinical trial.

References

ClinicalTrials.gov: A Study of Retatrutide (LY3437943) in Participants with Obesity and Cardiovascular Disease (TRIUMPH-3). Identifier: NCT06065515.
ClinicalTrials.gov: Efficacy and Safety of Retatrutide in Participants with Obesity or Overweight (TRIUMPH-1). Identifier: NCT05882045.
Eli Lilly and Company: Lilly's Phase 2 results for retatrutide published in The New England Journal of Medicine. (2023).
New England Journal of Medicine: Retatrutide, a GIP, GLP-1 and Glucagon Receptor Agonist, for People with Type 2 Diabetes. (2023).
FDA.gov: The Drug Development Process: Step 3 - Clinical Research.