GLP-1 & Amylin Approval Tracker: US, Canada, UK and EU

Approval is not one event. It is a sequence that runs at different speeds in Washington, Ottawa, London and Brussels — and the gap between the fastest and slowest jurisdiction is now measured in years, not months. This tracker puts the four major markets side by side so you can see exactly where each Lilly and Novo asset stands.

The Full Matrix

"No record" means no public authorization or filing was located at the review date; it does not establish that no submission exists. Approvals refer to the weight-management indication where a product has multiple indications.

How to Read the Status Labels

• Approved — a regulator has granted a marketing authorization for at least one indication. Prescribing still depends on label, price and coverage.
• Under review — a complete application has been accepted and the review clock is running. This is the only status where a decision date is genuinely near.
• Not filed — the sponsor has not submitted, or has announced an intention to submit. A filing target is not a decision date.
• Phase 3 / Phase 2 — clinical development. No regulator is involved yet, and the asset cannot be prescribed outside a trial.

Canada: The File That Actually Matters

Canada is not a footnote in this pipeline. It is a separately regulated market with its own submission, its own review clock and its own pricing process, and it is the market Standard Labs' readers ask about most.

Two facts stand out as of November 2026:

• CagriSema is under review in Canada. Health Canada accepted Novo's new drug submission in March 2026. Canadian decisions typically trail the US by months rather than years, but a 2026 Canadian authorization is unlikely.
• Orforglipron's Canadian status is not publicly established. The US and UK approvals and the EU opinion are documented; no Canadian authorization or filing was located at this review. Treat any claim that the pill is "available in Canada" as unverified until Health Canada's Drug Product Database shows a product.

For the Canadian context on the incumbent drug, see our tirzepatide Canada guide, the Mounjaro and generic pricing comparison, and what generic tirzepatide in Canada actually means.

The Gap Between Approval and Access

Every jurisdiction in this table separates the regulatory decision from the commercial one. The typical sequence is:

1. Submission — the sponsor files; the review clock starts.
2. Authorization — the regulator approves a label with specific indications and warnings.
3. Pricing — the sponsor sets a list price; in Canada, pan-Canadian reimbursement review follows.
4. Coverage — public and private payers decide who gets it and under what conditions.
5. Supply — manufacturing scale, device supply and distribution determine whether the label matters in practice.

Orforglipron illustrates the point. It has been approved in the US since April 2026 and in the UK since August 2026, and it is still working through European and other markets. Being first to approval does not mean being first to a pharmacy shelf in every country.

What Changes Next

• Q4 2026 CagriSema US decision The only near-term regulatory event in the pipeline. See the decision tracker.
• Q1 2027 Retatrutide US filing A BLA, subject to the classification dispute. See the filing analysis.
• 2027 Canadian CagriSema decision window Health Canada review continues; pricing and coverage follow authorization.
• 2027–2028 First potential retatrutide approvals Contingent on BLA acceptance and a 10–12 month review.

Related Reading

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Sources

• US FDA. FDA approves first new molecular entity under National Priority Voucher program. April 2026.
• EMA. Foundayo (orforglipron) EPAR — CHMP positive opinion, October 2026.
• Peptlas. CagriSema and cagrilintide regulatory status by jurisdiction. Verified October 2026.
• MedPath Trial. Retatrutide BLA timing and classification dispute. October 2, 2026.
• Health Canada. Drug Product Database — searched for orforglipron, cagrilintide and retatrutide at review date.