Orforglipron and CagriSema under review

What happened

Health Canada publishes a list of the submissions it has accepted for review. The page was last modified on 24 September 2026, and the list is current to 31 August 2026. Two GLP-1-based medicines are on it:

• Orforglipron calcium, sponsor Eli Lilly Canada Inc., accepted for review in January 2026. Lilly describes orforglipron as a once-daily oral GLP-1 medicine.
• Cagrilintide, semaglutide, sponsor Novo Nordisk Canada Inc., accepted in March 2026. Novo calls this combination CagriSema and describes it as a once-weekly injection that combines cagrilintide with semaglutide, the ingredient in Ozempic and Wegovy.

Health Canada marks both as a new active substance, meaning a medicine with an active ingredient that isn’t approved in Canada. A search of Health Canada’s Drug Product Database on 3 October 2026 found no authorized product containing cagrilintide. For orforglipron, the row adds a second note: the review is part of an “aligned review” with a health technology assessment organization. We explain that below.

Two dates matter for CagriSema, and they aren’t the same. Novo says it filed its submission with Health Canada in December 2025, for weight management. Health Canada’s list gives March 2026 as the month it accepted the submission for review. We haven’t found a filing date for orforglipron from Lilly or Health Canada.

The list’s class column reads “Drugs used in diabetes” for both medicines. That is a therapeutic class, so it doesn’t tell us which use each company asked Health Canada to approve. Novo says its CagriSema submission is for weight management. We haven’t confirmed which use Lilly submitted orforglipron for.

Separately, on 21 September 2026 Novo announced topline results from phase 3 trials of CagriSema, including REIMAGINE 5, which compared CagriSema with tirzepatide in adults with type 2 diabetes. Novo said CagriSema met the trial’s primary endpoints, change in HbA1c (a blood test measure of average blood sugar) and change in body weight. These are company-reported topline results, and we don’t publish trial figures. See our editorial policy.

What it means in Canada

Under review means Health Canada has accepted the company’s submission and is assessing it. Health Canada says a submission is added to the list after it has been accepted into review, and comes off when it is cancelled or a final decision is made. Being on the list is not an approval, and it doesn’t show which way the decision will go.

That assessment is called regulatory review. Health Canada checks a drug’s safety, efficacy and quality against the Food and Drugs Act. If the drug meets the requirements, Health Canada issues a Notice of Compliance, the authorization to sell it, along with a Drug Identification Number (DIN).

Neither product has that authorization yet. Health Canada’s list still shows both, and a search of its Drug Product Database on 3 October 2026 returned no product containing orforglipron or cagrilintide.

On timing, Novo says it expects Health Canada and US FDA decisions on CagriSema in the fourth quarter of 2026, which runs from 1 October to 31 December 2026. That is Novo’s expectation, not a Health Canada date. The list shows no decision date for either medicine, and we haven’t found a Canadian date for orforglipron from Lilly or Health Canada.

An aligned review means a health technology assessment body, such as Canada’s Drug Agency (CDA-AMC), assesses a drug’s value for public drug plans at the same time as Health Canada reviews it, instead of afterwards. The company chooses whether to use it. Health Canada’s note doesn’t name the organization, and we haven’t checked whether CDA-AMC has opened a review of either product. CagriSema’s row carries no aligned-review note.

Approval is also not coverage. Authorization lets a company sell a medicine in Canada. It doesn’t decide who pays. Public coverage runs through more steps:

1. Health Canada authorization. The safety, efficacy and quality review above.
2. CDA-AMC recommendation. CDA-AMC weighs clinical benefit and cost-effectiveness and recommends whether public plans outside Quebec should cover a drug. Its recommendations are non-binding. In Quebec, a separate agency, INESSS, does this job, and its recommendations are binding for public and private insurers there.
3. pCPA negotiation. The pan-Canadian Pharmaceutical Alliance (pCPA) decides whether to negotiate, then negotiates prices with manufacturers on behalf of public drug plans.
4. Plan listing. Each province, territory and federal plan decides for itself whether to add the drug to its formulary, the list of drugs the plan agrees to pay for.

Private insurers run their own evaluations and may refer to CDA-AMC’s work. See coverage across Canada for what we have confirmed by province.

What hasn’t changed

Nothing on the list changes what you can get or pay today. Neither medicine is authorized in Canada, so neither has a pharmacy price on our price pages. We list prices only for medications already on the market, such as Ozempic, Wegovy, Mounjaro and Zepbound.

We haven’t checked whether CDA-AMC or the pCPA has opened a file on either medicine, so we don’t state a coverage position for them.

We also looked for retatrutide and survodutide on the list. Neither appears in its data to 31 August 2026.

What happens next

Health Canada will make a final decision on each submission, or the company may cancel it. The entry then moves from the under-review list to the list of completed submissions, and Health Canada says you can check approvals in its Notice of Compliance database. Novo’s expected window for CagriSema is the fourth quarter of 2026, by its own statement. No date has been stated for orforglipron.

If either medicine is authorized, the coverage steps above come next, and each plan’s decision can differ from another’s. We don’t estimate how long those steps will take for either medicine. For Lilly’s separate heart-safety trial result, see our note on orforglipron’s ACHIEVE-4 trial.

If a website or clinic says it can supply orforglipron or CagriSema under its own name today, ask a pharmacist or prescriber about it first. Neither has a Health Canada authorization.

For options that are available now, see our prices and how providers compare.