What is retatrutide's current FDA approval status as of February 2026?

Retatrutide is still in Phase 3 clinical trials . Eli Lilly has completed enrollment for multiple Phase 3 studies but has not yet submitted a New Drug Application (NDA) to the FDA. Approval is not expected until 2027-2028.

What were the Phase 3 results for retatrutide?

Phase 3 trial data showed retatrutide delivered 24% average weight loss over 48 weeks—approximately 2% more than tirzepatide (Zepbound). The drug also showed benefits for fatty liver disease and metabolic health markers.

When will Eli Lilly submit retatrutide to the FDA?

Based on public trial timelines, FDA submission is expected in late 2026 or early 2027 . The exact date depends on final data analysis from ongoing Phase 3 studies.

How long does FDA review take after submission?

For new weight loss drugs, FDA review typically takes 6-12 months . If retatrutide receives Priority Review (possible given the efficacy data), approval could come faster. Realistic availability: Q4 2027 to Q2 2028.

Will retatrutide be covered by insurance when approved?

Unknown. Insurance coverage depends on FDA label indications, payer negotiations, and cost-effectiveness analysis. Initial pricing is expected to be similar to or higher than Zepbound ($1,000-$1,300/month retail).

Retatrutide FDA Approval Status (February 2026): Phase 3 Results & Expected Launch Date

The February 2nd Announcement: Lilly Confirms 2026 Timeline

On February 2, 2026, Eli Lilly officially confirmed during their Q4 earnings call that they remain "on track" to submit the New Drug Application (NDA) for Retatrutide to the FDA later this year. This announcement quells rumors of delays and solidifies a projected market launch for late 2026 or early 2027.

During the Q4 2025 earnings call in early February, Eli Lilly leadership provided the definitive "Go/No-Go" signal that analysts had been waiting for.

"On Track" for NDA: Despite rumors of supply chain delays, Lilly confirmed they are fully on schedule to submit the New Drug Application (NDA) for Retatrutide to the FDA in late 2026.
Manufacturing Readiness: Crucially, the announcement highlighted that Lilly has already begun "at-risk" manufacturing of the Retatrutide active pharmaceutical ingredient (API) at their new Concord, NC, and Limerick, Ireland facilities. This suggests they are preparing for a massive, supply-constrained launch similar to Zepbound, but with inventory building now—months before approval.
Confidence in the "Seven": The leadership team expressed "high confidence" in the remaining Phase 3 readouts, specifically noting that the safety profile regarding heart rate (a concern in Phase 2) has remained consistent and manageable in the larger Phase 3 populations.

The "Seven Readouts" Marathon

While the December 2025 results from TRIUMPH-4 (Knee Osteoarthritis) broke records with 28.7% weight loss, the real test happens now. Lilly has confirmed that seven additional Phase 3 trials are scheduled to conclude throughout 2026.

Trial Name	Condition Studied	Expected Completion	Status
TRIUMPH-4	Knee Osteoarthritis	Dec 2025	Complete (Success)
TRIUMPH-1	Obesity (Non-Diabetic)	May 2026	Recruiting/Active
TRIUMPH-2	Type 2 Diabetes	May 2026	Recruiting/Active
TRIUMPH-3	Cardiovascular Disease	Feb 2026	Imminent Readout
TRIUMPH-OSA	Sleep Apnea	Mid 2026	Active

Why the "Cardiovascular" Readout Matters (February/March 2026)

All eyes are now on TRIUMPH-3. This trial focuses on patients with established cardiovascular disease. If Retatrutide shows it can prevent heart attacks better than Mounjaro, it will likely secure a "fast-track" priority review from the FDA.

Retatrutide vs. Mounjaro: The Battle for Heart Health

Investors and cardiologists are closely watching TRIUMPH-3 to see if the "Triple G" mechanism offers a heart-health advantage over Mounjaro’s "Dual G" (tirzepatide).

The Glucagon Factor: Retatrutide’s unique activation of the Glucagon receptor improves lipid metabolism in the liver. Early Phase 2 data showed Retatrutide lowered LDL ("bad") cholesterol and triglycerides more aggressively than tirzepatide.
The Hypothesis: If this improved lipid clearance translates to fewer blocked arteries in TRIUMPH-3, Retatrutide could be marketed not just as a weight loss drug, but as a metabolic shield for the heart, potentially outperforming Mounjaro in long-term cardiovascular protection.

The "Fast-Track" Path: How Positive CV Data Accelerates Approval

A strong readout from TRIUMPH-3 in February or March 2026 could trigger an FDA Priority Review.

Standard vs. Priority: Standard FDA review takes 10 months. A "Priority Review" designation—granted to drugs that treat serious conditions and offer significant improvements in safety or effectiveness—cuts that timeline to 6 months.
The Strategy: If TRIUMPH-3 is a "home run," Eli Lilly will likely combine this safety data with the obesity efficacy data from TRIUMPH-1 to file for a broad, dual-indication approval. This would allow them to market the drug for "Obesity with Cardiovascular Risk" immediately upon launch, bypassing the years of delay that Wegovy faced in getting its heart-health label.

The Stakes of TRIUMPH-3: Beyond Weight Loss

While previous trials focused on the scale, TRIUMPH-3 (NCT05869903) is the first to rigorously test if Retatrutide can save lives. This trial focuses exclusively on patients with obesity and established cardiovascular disease (CVD)—a high-risk group that historically has had few treatment options beyond statins and surgery.

The "MACE" Endpoint: The FDA doesn't just want to see weight loss; they want to see a reduction in Major Adverse Cardiovascular Events (MACE). TRIUMPH-3 is measuring whether Retatrutide can directly prevent non-fatal heart attacks (myocardial infarction), strokes, and cardiovascular death.
Why It Matters: If Retatrutide shows a MACE reduction superior to the 20% benchmark set by Wegovy (semaglutide) in the SELECT trial, it effectively becomes the "Gold Standard" for cardiology, unlocking insurance coverage from plans that usually deny "lifestyle" weight loss drugs.