When Will Retatrutide Be Available? 3 Ways to Access It Now (2026)
Retatrutide is NOT FDA approved. But there are 3 current legitimate access pathways — and a projected 2027–2028 approval window.
Retatrutide is in Phase 3 clinical trials. It is not FDA approved. It cannot be legally prescribed. Access is limited to specific pathways described below.
Clinical Trial Enrollment (Free Drug, Regulated)
The most legitimate access pathway. Phase 3 trials are enrolling at sites across the US and internationally. Participants receive the drug at no cost, along with study-related medical care.
- •BMI ≥ 30, or ≥ 27 with at least one weight-related condition (hypertension, dyslipidemia, sleep apnea, T2D)
- •No current or recent GLP-1 receptor agonist use (semaglutide, tirzepatide)
- •No personal or family history of medullary thyroid carcinoma (MTC) or MEN2
- •No active pancreatitis or severe GI conditions
- •Willing to attend regular in-person study visits (typically monthly)
- •No pregnancy or planned pregnancy during trial period
Research-Grade via Physician Oversight
Some physicians in the US work with compounding pharmacies and research suppliers to provide Retatrutide under physician supervision. This operates in a legal gray area — there is no FDA-approved reference product, so standard compounding rules may not apply.
- ✓Physician oversight and regular monitoring
- ✓Third-party COA with HPLC purity ≥98%
- ✓Mass spectrometry verification
- ✓US-based compounding facility
- ✗No physician involvement
- ✗Overseas sourcing without COA
- ✗No purity testing documentation
- ✗Claimed to be FDA approved when it is not
Telehealth Platforms (Emerging)
A small number of telehealth platforms are beginning to offer physician-supervised Retatrutide through compounding pharmacies. This space is evolving rapidly as demand grows ahead of FDA approval.
View Telehealth Provider Guide →FDA Approval Timeline: What to Expect
Phase 2 results published. Significant weight reduction data established.
Phase 3 trials enrolling. Cardiovascular outcomes, broader populations.
Manufacturer submits New Drug Application to FDA. Estimated based on Phase 3 completion timeline.
FDA standard review: 10–12 months. Priority review (if granted): 6 months.
Commercial launch. Prescription availability. Telehealth platforms scale. Insurance coverage begins.
What Changes After FDA Approval
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Frequently Asked Questions
Is Retatrutide available right now?
Retatrutide is NOT FDA approved and cannot be legally prescribed by a doctor or purchased at a pharmacy. The three current legitimate access pathways are: (1) clinical trial enrollment (free drug, regulated), (2) physician-supervised research-grade access (off-label, legal gray area), and (3) some telehealth platforms offering compounded versions (emerging, check current status). Do not purchase from overseas pharmacies or sources without physician oversight.
When will Retatrutide be FDA approved?
Based on the Phase 3 trial timeline, the most likely scenario is: Phase 3 data reads out in 2025–2026, NDA (New Drug Application) filing in 2026–2027, FDA review (typically 10–12 months), and approval in 2027–2028. This is an estimate — trial results, FDA priority review status, and regulatory decisions can shift the timeline.
Can I get Retatrutide through a clinical trial?
Yes — this is the most legitimate current access pathway. Phase 3 trials are enrolling at sites across the US. The drug is free to participants. You can search for open sites at ClinicalTrials.gov. Typical eligibility: BMI ≥ 30 (or ≥ 27 with comorbidity), no recent GLP-1 use, no history of MTC or MEN2.
Will insurance cover Retatrutide after FDA approval?
Insurance coverage will depend on your plan. Obesity drugs have historically had poor coverage in the US (many Medicare plans excluded them until 2024). However, the trend is improving. If Retatrutide shows superior outcomes in Phase 3, it may earn broader coverage. Initial out-of-pocket cost will likely be $800–1,200/month without insurance, similar to current GLP-1 pricing.
What are the differences between research-grade and pharmaceutical Retatrutide?
Pharmaceutical Retatrutide (when approved) is manufactured to FDA GMP standards with verified purity, sterility, and dosing. Research-grade versions from compounding or peptide vendors vary in quality — look for third-party COA (certificate of analysis), HPLC purity ≥98%, and mass spectrometry verification. Research-grade is sold for laboratory use only and is not intended for human use under current FDA regulations.