Orforglipron (Foundayo): Approval Status, Trials, Side Effects and Price

As of October 5, 2026, orforglipron is a once-daily GLP-1 pill from Eli Lilly. The FDA approved it as Foundayo on April 1, 2026, for weight management in adults, and the UK followed on August 10, 2026, for weight management and type 2 diabetes^[1,2,4]. In the US it isn’t approved for type 2 diabetes: Lilly says it has submitted that application^[23]. Mexico’s COFEPRIS lists a 2026 registration under the name Foundayz^[10]. In the European Union, and so in Spain, it isn’t authorized: the European Medicines Agency (EMA) has been reviewing it since January 2026^[5,9]. In its main trial, the top dose lowered body weight by 11.2% on average over 72 weeks, vs. 2.1% on placebo^[13].

If you’re considering it, talk to your doctor. How it compares with the semaglutide pills is in GLP-1 pills.

What orforglipron is

It’s a GLP-1 receptor agonist: it activates the receptor of GLP-1, a gut hormone involved in appetite and blood sugar. According to the US label, Foundayo binds to and activates the human GLP-1 receptor, decreases food intake, an effect likely mediated by decreased appetite, and delays gastric emptying; the delay is largest after the first dose and diminishes over time^[1].Dotted underline: a drug-label fact; hover over it to see the date it was checked.

Semaglutide and liraglutide are peptides, chains of amino acids (the family is explained in what are GLP-1 medications). Orforglipron is a small, non-peptide molecule, according to the ATTAIN-1 paper^[13], so it works as an ordinary pill.

How the label says it’s taken

• By mouth once daily, with or without food, swallowed whole without breaking, crushing or chewing, and no more than one tablet per day^[1].
• Tablets come in six strengths: 0.8, 2.5, 5.5, 9, 14.5 and 17.2 mg^[1].
• The label sets no fasting window and no water limit^[1]. The MHRA describes it as a tablet that can be taken at any time of day with no food or water restrictions^[4].

Oral semaglutide differs: its US label calls for an empty stomach in the morning, with up to 4 ounces of water and no other liquids, and a wait of at least 30 minutes before eating, drinking or taking other oral medications^[21]. Orforglipron’s label gives an absolute bioavailability of 77% after a 0.8 mg dose, and in its food-effect study no clinically relevant food effect was observed: total exposure (AUC) fell by 19% and peak concentration by 26% with food, compared with the fasted state^[1]. The label also gives an elimination half-life of about 29 to 49 hours, with steady state reached after about 1 week of daily dosing^[1].

Dose steps in the label. The starting dosage is 0.8 mg once daily, increased to 2.5 mg after at least 30 days and to 5.5 mg after at least 30 more days. The dosage may then be increased to the next level (9, 14.5 or 17.2 mg) after at least 30 days on the current dosage, based on treatment response and tolerability; the maximum is 17.2 mg once daily^[1]. The escalation is meant to reduce the risk of gastrointestinal side effects^[1]. Which dose fits a given person, and when to change it, is the prescriber’s decision.

Approval status by country

BMI is body mass index, in kg/m²; what it misses is in what BMI measures. The FDA approved Foundayo under its Commissioner’s National Priority Voucher pilot program, 50 days after filing^[3]. The one later supplement in Drugs@FDA, S-003 (August 4, 2026), is a labeling change, not a new indication^[2].

US indication in full. In combination with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. Use with another GLP-1 receptor agonist is not recommended^[1].

Mexico. The registration falls under fraction IV of article 226 of the General Health Law: prescription medicines that can be refilled as many times as the prescriber indicates^[10,11].

What the trials show

All the trials below were phase 3 and funded by Eli Lilly^{[13,14,15,16,17,18,19,20]}. They used an investigational formulation in doses of up to 36 mg; the US label presents its trial data as equivalent Foundayo doses^[1]. Most have a summary page in studies.

Weight: ATTAIN-1 and ATTAIN-2

ATTAIN-1 (without diabetes). 3,127 adults with obesity, or overweight and at least one weight-related complication, for 72 weeks, with diet and activity counseling. They took 6, 12 or 36 mg, started at 1 mg and increased every 4 weeks^[13]. The label reports them as Foundayo 5.5, 9 and 17.2 mg, with a slightly different analysis^[1,13]:

A 95% CI (confidence interval) is the range where the true effect probably lies.

ATTAIN-2 (with type 2 diabetes). 1,613 adults with type 2 diabetes and a BMI of 27 or more, for 72 weeks. Weight changed by −5.1%, −7.0% and −9.6% on 6, 12 and 36 mg, vs. −2.5% on placebo; the difference on 36 mg was −7.1 percentage points (95% CI: −8.2 to −6.1)^[14]. The label reports the same changes on 5.5, 9 and 17.2 mg, with a difference of −7.1 points (95% CI: −8.1 to −6.1)^[1]. People with type 2 diabetes lost less weight, as with the rest of the family; see how much weight people lose on GLP-1 medications and the trial results chart, which plots both trials.

ATTAIN-MAINTAIN (after the injections). 376 adults without diabetes who had finished 72 weeks on tirzepatide or semaglutide in another trial switched to orforglipron or placebo for 52 weeks. Among those whose weight had plateaued, orforglipron kept 74.7% of the weight lost on tirzepatide, vs. 49.2% on placebo (difference of 25.5 points; 95% CI: 14.5 to 36.5). After semaglutide, it was 79.3% vs. 37.6% (difference of 41.7 points; 95% CI: 24.4 to 59.0)^[15]. No group stayed on the injection, so it doesn’t show whether switching works as well as continuing. Stopping altogether is covered in stopping GLP-1 medications and weight regain.

Type 2 diabetes: the ACHIEVE trials

HbA1c is average blood sugar over the past two to three months. Results on the top trial dose, 36 mg:

Open-label means participants knew which drug they were taking. Dapagliflozin is an SGLT2 inhibitor, another type of diabetes pill.

• ACHIEVE-1. Weight fell by 7.6% on 36 mg, vs. 1.7% on placebo^[16].
• ACHIEVE-2. Digestive side effects affected 46% to 54% on orforglipron, vs. 12% on dapagliflozin, and 15%, 18% and 20% on the three orforglipron doses stopped study treatment for any reason, vs. 6%. There was no severe hypoglycemia (low blood sugar)^[17].
• ACHIEVE-3. Orforglipron lowered HbA1c more, at a cost: digestive side effects in 58% to 59% vs. 37% to 45% on oral semaglutide, and more people stopped because of side effects (9% to 10% vs. 4% to 5%)^[18].
• ACHIEVE-5. Weight fell by 5.4% on 36 mg; on placebo it barely changed (0.2%). Orforglipron didn’t increase clinically significant hypoglycemia vs. placebo^[20].

ACHIEVE-4 (heart safety). Published in The Lancet on September 30, 2026: 2,749 adults with type 2 diabetes, overweight or obesity, and established cardiovascular or chronic kidney disease, randomized to orforglipron (up to 36 mg, equivalent to the 17.2 mg tablet) or insulin glargine, open-label. Over a median of 2 years, a major cardiovascular event (cardiovascular death, nonfatal heart attack, nonfatal stroke or hospitalization for unstable angina) occurred in 4.2% on orforglipron and 5.0% on insulin glargine (hazard ratio 0.84; 95% CI: 0.59 to 1.20). That met the trial’s goal of showing orforglipron wasn’t worse (the upper limit had to stay below 1.8); it doesn’t show it lowers cardiovascular risk. Digestive side effects affected 62.1% vs. 14.2%, and blood sugar below 54 mg/dL occurred in 6.8% vs. 19.2%^[19].

No head-to-head trial against a GLP-1 injection for weight has been published. The comparison with the other pills, including indirect analyses funded by each manufacturer, is in GLP-1 pills.

What is only in press releases

• The US type 2 diabetes application. Lilly’s second-quarter 2026 release (August 5, 2026) mentions it^[23]. I haven’t found an FDA record of it, and Drugs@FDA lists no approval for that use^[2].
• ACHIEVE-4 blood sugar, weight and deaths. The paper’s abstract doesn’t give them. Lilly’s release reports, at 52 weeks, HbA1c −1.6 points on orforglipron vs. −1.0 on insulin glargine, from a baseline of 8.22%, and weight −8.8% vs. +1.7%, plus a hazard ratio for death from any cause of 0.43 (95% CI: 0.25 to 0.75), in an analysis the release says wasn’t controlled for multiple testing^[24]. The abstract counts 19 deaths (1.4%) on orforglipron and 43 (3.2%) on insulin glargine^[19]. A press release is written by the company; only the full paper lets outside readers check those figures.

Orforglipron side effects in the US label

The label pools the two weight trials (ATTAIN-1 and ATTAIN-2): 3,155 adults treated with Foundayo for up to 72 weeks^[1]. Digestive effects lead the list. Nausea affected 26%, 34% and 35% on 5.5, 9 and 17.2 mg, vs. 10% on placebo; constipation 20%, 27% and 24%, vs. 9%; diarrhea 21%, 23% and 25%, vs. 11%; and vomiting 13%, 21% and 24%, vs. 4%^[1]. Indigestion and abdominal pain complete the six most common. The other reactions in the label’s table 1^[1]:

Other figures from section 6.1 of the label^[1]:

• Digestive effects overall. They affected 60%, 68% and 69% on 5.5, 9 and 17.2 mg, vs. 37% on placebo. Of those who had them, 60% reported mild, 36% moderate and 4% severe reactions. Nausea, vomiting and diarrhea were more frequent during dose escalation and decreased over time.
• Stopping treatment. 8% stopped because of side effects (6%, 9% and 10% by dose), vs. 3% on placebo, mostly because of digestive effects.
• Pancreatitis. Acute pancreatitis was confirmed in 6 people on Foundayo (0.14 per 100 years of exposure) and 1 on placebo (0.04).
• Heart rate and blood pressure. Heart rate rose by an average of 4 to 5 beats per minute, vs. 0.5 on placebo. Low blood pressure affected 2%, vs. 0.5%, and was more frequent in people taking blood pressure medication (4%).
• Gallbladder. Gallstones were reported in 1%, vs. 0.7% on placebo, and acute gallbladder inflammation in 0.4%, vs. 0.3%.
• Hair loss. It was associated with weight reduction and was more frequent in women (7%) than in men (0.9%) on Foundayo.
• Low blood sugar. In ATTAIN-2 (type 2 diabetes), glucose below 54 mg/dL was reported in 2% on Foundayo vs. 0.2% on placebo, and in 7% of those also taking a sulfonylurea.

For the digestive symptoms: nausea on GLP-1 medications: what to eat and constipation on GLP-1 medications.

Boxed warning, contraindications and other warnings

The boxed warning. It’s the most prominent warning on an FDA label. Foundayo’s covers thyroid C-cell tumors: GLP-1 receptor agonist products that are active in rats and mice have caused thyroid C-cell tumors (adenomas and carcinomas) in rodents at clinically relevant exposures. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents; the human relevance of these rodent tumors has not been determined^[1]. It also states the two thyroid contraindications below, asks prescribers to counsel patients on the potential risk of medullary thyroid carcinoma (MTC) and the symptoms of thyroid tumors (a mass in the neck, trouble swallowing, shortness of breath or persistent hoarseness), and states that routine monitoring of serum calcitonin or thyroid ultrasound is of uncertain value for early detection of MTC^[1].

Contraindications. A personal or family history of MTC, multiple endocrine neoplasia syndrome type 2 (MEN 2), or a known serious hypersensitivity to orforglipron or any of the tablet’s ingredients^[1].

Other warnings. Acute pancreatitis; severe gastrointestinal reactions (not recommended with severe gastroparesis); acute kidney injury from dehydration; hypoglycemia, with a higher risk alongside insulin or an insulin secretagogue such as a sulfonylurea; serious allergic reactions; diabetic retinopathy complications in people with type 2 diabetes; acute gallbladder disease; and pulmonary aspiration during general anesthesia or deep sedation^[1]. The label asks prescribers to instruct patients to tell their healthcare providers they’re taking Foundayo before any planned surgery or procedure^[1].

Oral contraceptives. The label advises people using oral hormonal contraceptives to switch to a non-oral method, or add a barrier method, for 30 days after starting Foundayo and for 30 days after each dose increase. Its effect on oral contraceptive absorption has not been evaluated in a clinical trial; non-oral hormonal contraceptives should not be affected^[1].

Other medicines. According to the label, because it delays gastric emptying, Foundayo may affect the absorption of other oral medications. With a strong CYP3A4 inhibitor (a drug that slows its breakdown in the liver), the maximum dosage is 9 mg once daily, and strong inhibitors that also inhibit OATP1B, such as ritonavir, should be avoided; strong CYP3A4 inducers should be avoided too; and simvastatin shouldn’t exceed 20 mg a day^[1]. Your prescriber and pharmacist can check your other medications.

Pregnancy, breastfeeding and the liver. According to the label, Foundayo may cause fetal harm and should be discontinued when pregnancy is recognized; it is not recommended while breastfeeding or in severe liver impairment^[1]. If you’re pregnant, planning a pregnancy or breastfeeding, talk to your doctor.

Foundayo price and availability

Drugs@FDA lists every Foundayo strength as prescription only^[2]. I don’t list prices: they change often, and what a person pays depends on their insurance. Lilly’s approval release (April 1, 2026) gave a self-pay price for the lowest dose only, and none for the others^[22]. It isn’t a reference for other countries.

• United Kingdom. When it was authorized, it wasn’t available through the NHS; decisions on NHS use follow an evaluation by NICE^[4].
• Spain and the rest of the EU. Not authorized, so no price^[5,9].
• Mexico. It’s registered as Foundayz^[10]. On October 5, 2026, Lilly México’s online store listed the two starting strengths, 0.8 mg and 2.5 mg, and none of the higher ones; I don’t link to stores. The prices and the monthly math are in my orforglipron price guide for Mexico (in Spanish).

As a new molecular entity approved in 2026, orforglipron has no approved generic that I’ve found^[2,3]. For older GLP-1 drugs, see generic semaglutide: patents and approvals.

When it could reach the European Union

It depends on the EMA. According to the agency, assessing a new medicine takes up to 210 “active” days of expert review, plus one or two pauses while the company answers questions: usually around a year in all^[7]. Orforglipron’s review started on January 22, 2026 and restarted on July 20, after the first pause^[5]. The draft agenda of the EMA’s medicines committee (CHMP) for September 14–17, 2026 listed it at day 180, for adoption of a “list of outstanding issues,” the second round of questions^[6]. After a positive opinion, the European Commission has 67 days to decide^[8]. Authorization isn’t the same as being sold: launch and, where it applies, reimbursement come afterward.

Frequently asked questions

Is orforglipron the same as an Ozempic pill?

No. Ozempic is semaglutide, a peptide from Novo Nordisk; orforglipron is a different, non-peptide molecule from Eli Lilly^[13]. The semaglutide pills, including Rybelsus and Ozempic tablets^[21], are covered in GLP-1 pills, and the family’s names in GLP-1 generic and brand names.

Is Foundayo approved for type 2 diabetes?

Not in the US: its FDA indication is weight management only, and Lilly says it has submitted the diabetes application^[1,23]. In the UK, the MHRA authorized it for both weight management and type 2 diabetes^[4].

Do you have to take Foundayo on an empty stomach?

No. The label says once daily, with or without food, and sets no water limit^[1].

Is orforglipron available in Mexico?

It has a COFEPRIS registration as Foundayz, prescription only^[10]. On October 5, 2026, Lilly México’s online store listed the 0.8 mg and 2.5 mg tablets; I haven’t checked pharmacies, and I haven’t found an official launch date. COFEPRIS advises against buying medicines online, on social media or from informal sellers, and against those without a registration or labeled in another language^[12].

Are Foundayo and Foundayz the same?

Both are orforglipron from Eli Lilly: Foundayo in the US and the UK, Foundayz in the COFEPRIS registration list^[2,4,10].