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New Weight Loss Medications in 2026: What the FDA Has Approved

FDA-approved weight loss drugs as of October 2026: Wegovy, the Wegovy pill, Wegovy HD, Zepbound and Foundayo, plus what is still investigational.

Before and after photo of a Healthy Weight Loss 4 U patient; individual results vary
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By the Healthy Weight Loss 4 U Clinical Content Team · Published October 19, 2026 · Updated October 19, 2026 · 9 min read

In short

As of October 19, 2026, the FDA has approved injectable Wegovy (June 4, 2021) [7], Zepbound (November 8, 2023) [9], the Wegovy pill (announced December 22, 2025) [4], Wegovy HD 7.2 mg (March 19, 2026) [8] and Foundayo, or orforglipron (April 1, 2026) [2] for weight management. In the pivotal trials, average weight change in the highest-dose arms ranged from 11.1% with Foundayo to 20.9% with Zepbound, versus 2.1% to 3.1% with placebo [1][6][10]. CagriSema and retatrutide are still investigational [12][14].

Key takeaways

  • Foundayo (orforglipron) was announced as FDA-approved on April 1, 2026; in its label's 3,127-person trial, the top-dose group lost 11.1% of body weight at 72 weeks versus 2.1% with placebo [1][2].
  • The Wegovy pill (oral semaglutide 25 mg) was approved in December 2025; in OASIS 4 (307 adults), mean weight change was -13.6% versus -2.2% with placebo at 64 weeks [4][5].
  • Wegovy HD (7.2 mg), approved March 19, 2026, produced 18.7% mean weight loss regardless of adherence in the STEP UP trial of about 1,400 adults over 72 weeks [8].
  • Zepbound's label shows -20.9% at the 15 mg level versus -3.1% with placebo at 72 weeks in 2,539 adults [9][10].
  • CagriSema was submitted to the FDA on December 18, 2025, with a decision expected in Q4 2026, and Lilly plans to submit retatrutide in Q1 2027; neither is approved for use [11][12][14].

Which weight loss medications has the FDA approved as of October 2026?

The FDA has approved five GLP-1-based products for chronic weight management: injectable Wegovy (semaglutide), Zepbound (tirzepatide), the Wegovy pill, Wegovy HD, and Foundayo (orforglipron). Older prescription options exist as well. The National Institute of Diabetes and Digestive and Kidney Diseases lists orlistat, phentermine-topiramate, naltrexone-bupropion, liraglutide, and setmelanotide, which is limited to certain rare genetic causes of obesity [15].

The NIDDK states that a weight management medicine may be prescribed to an adult with a BMI of 30 or greater, or a BMI of 27 or greater with weight-related health problems such as high blood pressure or type 2 diabetes [15]. Each of the newer labels is written the same way: the medicine is used together with a reduced-calorie diet and increased physical activity [1][3][10].

This article is education only. It is not a recommendation to use any product, and whether a medication is appropriate for a person is a decision for a licensed clinician after an evaluation.

FDA-approved GLP-1-based weight management products and their pivotal results (cross-trial numbers are not head-to-head comparisons)
ProductFDA actionFormPivotal result (top-dose arm vs placebo)
Wegovy (semaglutide) injectionApproved June 4, 2021 [7]Injection [3]-14.9% vs -2.4% at 68 weeks, label Study 1, 1,961 adults [6]
Wegovy HD (semaglutide 7.2 mg)Approved March 19, 2026 [8]Once-weekly injection, single-dose pen [3][8]18.7% mean loss regardless of adherence, STEP UP, about 1,400 adults, 72 weeks [8]
Wegovy pill (oral semaglutide 25 mg)Announced December 22, 2025 [4]Once-daily tablet [4]-13.6% vs -2.2% at 64 weeks, OASIS 4, 307 adults [5]
Zepbound (tirzepatide)Approved November 8, 2023 [9]Injection: single-dose pen, vial or KwikPen [10]-20.9% vs -3.1% at 72 weeks, label Study 1, 2,539 adults [10]
Foundayo (orforglipron)Announced April 1, 2026 [2]Once-daily tablet, taken with or without food [1]-11.1% vs -2.1% at 72 weeks, 3,127 adults [1]

What is injectable Wegovy approved for, and what did the trials show?

Injectable Wegovy was approved on June 4, 2021 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with a BMI of 30 or higher, or 27 or higher with at least one weight-related condition [7]. The label, revised June 2026, now lists three injection indications: weight reduction and long-term maintenance in adults and in patients aged 12 and older with obesity, reducing major cardiovascular events in adults with established cardiovascular disease and obesity or overweight, and treating noncirrhotic MASH with moderate to advanced fibrosis in adults under accelerated approval [3].

In the label's first weight trial, 1,961 adults with obesity or overweight and no diabetes were studied. At week 68, mean body weight fell 14.9% with Wegovy versus 2.4% with placebo, and 83.5% of the Wegovy group lost at least 5% of body weight versus 31.1% with placebo [6]. In the second study, 807 adults with type 2 diabetes lost 9.6% versus 3.4% with placebo [6]. People with diabetes lost less on average, a pattern that also appears in the tirzepatide and orforglipron labels [6][10][1].

The cardiovascular indication rests on a randomized trial of 17,604 patients with established cardiovascular disease and obesity or overweight, followed for a median of 41.8 months. Major cardiovascular events occurred in 6.5% of the Wegovy group versus 8% with placebo (hazard ratio 0.80, 95% CI 0.72 to 0.90) [3].

On March 19, 2026, Novo Nordisk announced FDA approval of a higher once-weekly dose, Wegovy HD (semaglutide 7.2 mg), to reduce excess body weight and maintain the reduction long term [8]. The current label lists 7.2 mg as a separate single-dose pen [3]. In STEP UP, a 72-week trial of about 1,400 adults with obesity, the company reported mean weight loss of 20.7% if all participants adhered and 18.7% regardless of adherence, with 31.2% reaching at least 25% weight loss [8]. In STEP UP T2D, about 500 adults with type 2 diabetes lost 14.1% (adherent) and 13.2% (regardless of adherence) [8].

One limit on those figures: the announcement is a company document and reports only the 7.2 mg group, so it does not give the placebo or lower-dose comparators [8]. Which dose suits a person is a prescriber's decision.

What is the Wegovy pill, and what did OASIS 4 show?

The Wegovy pill is once-daily oral semaglutide 25 mg, and Novo Nordisk announced on December 22, 2025 that the FDA had approved it to reduce excess body weight, maintain weight reduction long term, and reduce the risk of major cardiovascular events [4]. The current label states that the tablets are for adults, with the weight and cardiovascular indications, and the MASH indication belongs to the injection only [3].

OASIS 4 randomized 307 adults without diabetes who had obesity, or overweight with a weight-related condition, in a 2:1 ratio: 205 to oral semaglutide 25 mg and 102 to placebo [4][5]. The primary measurements came at week 64. Estimated mean weight change was -13.6% with the pill versus -2.2% with placebo, a difference of -11.4 percentage points (95% CI -13.9 to -9.0) [5]. The company also reports 16.6% mean loss if all participants adhered to treatment [4].

Gastrointestinal adverse events were more frequent with the pill: 74.0% versus 42.2% with placebo [5]. The company states the safety profile was comparable to earlier semaglutide weight-management trials [4]. OASIS 4 is a single trial of 307 people, so it is smaller than the 1,961-person trial behind the injection label [5][6].

What is Zepbound approved for, and what did the trials show?

Zepbound (tirzepatide) was approved on November 8, 2023 for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity, in adults with obesity (BMI 30 or higher) or overweight (BMI 27 or higher) with at least one weight-related condition [9]. The label, revised August 2026, lists two indications: reducing excess body weight and maintaining the reduction in adults with obesity or overweight with a weight-related condition, and treating moderate to severe obstructive sleep apnea in adults with obesity [10].

The first pivotal trial, SURMOUNT-1, enrolled 2,539 adults over 72 weeks [9]. In the label's Study 1, mean body weight change was -15.0% (5 mg), -19.5% (10 mg) and -20.9% (15 mg), against -3.1% with placebo [10]. In the label's Study 2 in adults with type 2 diabetes, the change was -12.8% (10 mg) and -14.7% (15 mg), against -3.2% with placebo [10].

Zepbound is supplied as single-dose pens or vials, and as a multi-dose KwikPen [10]. The label says it should not be coadministered with other tirzepatide-containing products or any GLP-1 receptor agonist [10].

What is Foundayo (orforglipron), and when was it approved?

Foundayo (orforglipron) is a once-daily pill that Eli Lilly announced as FDA-approved on April 1, 2026 for adults with obesity, or with overweight and weight-related medical problems, together with a reduced-calorie diet and more physical activity [2]. Its label (initial U.S. approval 2026, revised July 2026) says the tablet is taken once daily with or without food and swallowed whole, and that using it with another GLP-1 receptor agonist is not recommended [1].

Per its label, the trials were a 72-week study of 3,127 adults without diabetes (Trial 1) and a 72-week study of 1,613 adults with type 2 diabetes (Trial 2) [1]. Lilly's announcement names these ATTAIN-1 and ATTAIN-2 [2]. In Trial 1, mean weight change at week 72 was -7.4%, -8.3% and -11.1% across the three dose groups, versus -2.1% with placebo. In Trial 2, the top-dose group changed -9.6% versus -2.5% with placebo [1].

Lilly also reports ATTAIN-1 results two ways. Among participants who stayed on treatment, the top dose produced an average loss of 12.4% versus 0.9% with placebo. Among all participants regardless of completion, it was 11.1% versus 2.1% [2]. The second figure matches the label and is the more conservative one.

Foundayo's initial U.S. approval was in 2026, so the post-approval safety record is short compared with the products first approved in 2021 and 2023 [1][6][9].

What do the labels warn about, and how does this differ from compounded versions?

Wegovy, Zepbound and Foundayo all carry a boxed warning about thyroid C-cell tumors and the same core contraindications. The warning rests on rodent findings, and the labels say the relevance in humans is unknown or not determined [3][10][1]. All three are contraindicated in people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2, or a serious hypersensitivity reaction to the product [3][10][1]. Foundayo's label adds that orforglipron is not pharmacologically active in rats or mice and did not produce rodent tumors, while stating human relevance has not been determined [1].

Other warnings listed in the Foundayo label include pancreatitis, severe gastrointestinal reactions, acute kidney injury due to volume depletion, hypoglycemia, hypersensitivity, diabetic retinopathy complications in type 2 diabetes, acute gallbladder disease and pulmonary aspiration during anesthesia or deep sedation [1]. The Wegovy label lists a similar set plus heart rate increase [3].

At the top dose in Foundayo's label, the most common adverse reactions versus placebo were nausea (35% vs 10%), diarrhea (25% vs 11%), constipation (24% vs 9%) and vomiting (24% vs 4%) [1].

Compounded versions are a separate category. The FDA states that compounded drugs are not FDA-approved and that the agency does not review them for safety, effectiveness or quality before they are marketed. As of May 31, 2026, it had received 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide, and it believes events are likely underreported [16].

What is still investigational: CagriSema and retatrutide?

CagriSema and retatrutide are not FDA-approved. Novo Nordisk submitted a new drug application for CagriSema (cagrilintide 2.4 mg with semaglutide 2.4 mg) on December 18, 2025, and its Q2 2026 investor presentation says a US decision in obesity is expected in Q4 2026 [11][12]. We found no approval announcement in the FDA and company sources reviewed through October 19, 2026.

In REDEFINE 1, a 68-week phase 3 trial of 3,417 adults without diabetes, CagriSema produced 20.4% weight loss regardless of adherence versus 3.0% with placebo, and 22.7% versus 2.3% if all participants adhered [11]. These are company-reported figures from a press release.

Retatrutide is Lilly's triple agonist. In TRIUMPH-1, an 80-week trial of 2,339 adults with obesity or overweight, the 12 mg group lost 28.3% (efficacy estimand) or 25.0% (treatment-regimen estimand) versus 2.2% or 3.9% with placebo [13]. Dysesthesia, an altered skin sensation, occurred in 12.5% of the 12 mg group versus 0.9% with placebo, and 11.3% stopped for adverse events versus 4.9% with placebo [13]. In July 2026, Lilly reported TRIUMPH-2 (1,152 adults with type 2 diabetes, 20.8% vs 4.0% with placebo) and TRIUMPH-3 (1,949 adults with severe obesity and cardiovascular disease, 22.6% vs 3.2%) and said it plans to submit retatrutide for US approval in Q1 2027 [14]. Lilly states retatrutide is investigational and legally available only in clinical trials [13].

Mean weight change at the top dose in pivotal trials, percent (approved products and two investigational ones; trial lengths 64 to 80 weeks)

Source: [1][5][6][8][10][11][13] product labels and trial reports [1][5][6][10]; company announcements [8][11][13]. Regardless-of-adherence estimates where reported; placebo groups changed 2.1% to 3.9%. Different populations and designs, so not head-to-head.

What this means in practice

  • Five GLP-1-based products are FDA-approved for weight management as of this writing. Two are daily tablets (the Wegovy pill and Foundayo) and three are injections [1][3][4][10].
  • Trial averages are not predictions. In the Wegovy label, 83.5% of the treated group lost at least 5% of body weight, but 31.1% of the placebo group did too, and individual results vary widely [6].
  • Cross-trial comparisons are unreliable. The trials differed in length (64 to 80 weeks), population and statistical method, so a 20.9% result and an 11.1% result are not a head-to-head contest [1][10].
  • Every approved product carries a boxed warning about thyroid C-cell tumors and is contraindicated with a personal or family history of medullary thyroid carcinoma or MEN 2 [1][3][10].
  • Compounded drugs are not FDA-approved and the FDA does not review them for safety, effectiveness or quality [16].
  • Approvals move quickly. Labels were revised as recently as July and August 2026, so check the current DailyMed label or ask a clinician for the latest [1][10].

When to talk to a clinician

Talk to a licensed clinician before starting, switching or stopping any weight management medication, and sooner if you have a history of thyroid cancer, pancreatitis, gallbladder disease, kidney problems or diabetic eye disease, because these appear in the labels as contraindications or warnings [1][3][10]. If you are or may become pregnant, take other medicines, or have had side effects from a prior medication, raise it as well.

At Healthy Weight Loss 4 U, every program begins with a clinician evaluation. That evaluation is the place to ask which, if any, of these approved options fits your history, and to ask about the investigational ones and about brand-name versus compounded products.

Frequently asked questions

What is the newest FDA-approved weight loss pill?
Eli Lilly announced FDA approval of Foundayo (orforglipron) on April 1, 2026. It is a once-daily tablet taken with or without food for adults with obesity, or overweight with a weight-related condition. In its label's 72-week trial of 3,127 adults, the top-dose group lost 11.1% of body weight versus 2.1% with placebo [1][2].
How is the Wegovy pill different from the Wegovy injection?
Both contain semaglutide. The pill is a once-daily oral 25 mg tablet, announced as approved on December 22, 2025, and its label covers adults only, with weight and cardiovascular indications but not MASH, which belongs to the injection. In OASIS 4, 307 adults lost a mean 13.6% versus 2.2% with placebo at week 64 [3][4][5].
What is Wegovy HD?
Wegovy HD is a once-weekly semaglutide 7.2 mg injection that the FDA approved on March 19, 2026 to reduce excess body weight and maintain the reduction long term. In STEP UP, about 1,400 adults averaged 18.7% weight loss regardless of adherence at 72 weeks, according to the company. A prescriber decides which dose, if any, is suitable [8].
Is CagriSema FDA-approved?
Not as of the sources reviewed through October 19, 2026. Novo Nordisk filed an application on December 18, 2025, and its Q2 2026 presentation expects a US decision in obesity in Q4 2026. In the 3,417-adult REDEFINE 1 trial, it produced 20.4% weight loss regardless of adherence versus 3.0% with placebo [11][12].
Is retatrutide approved?
No. Retatrutide is investigational and, per Lilly, legally available only in clinical trials. Lilly reported TRIUMPH-1 results in May 2026 and TRIUMPH-2 and TRIUMPH-3 in July 2026, and said it plans to submit it for US approval in Q1 2027. Any product sold online as retatrutide has not been approved by the FDA [13][14].
Which approved weight loss medication works best?
Trials cannot answer that, because they differ in length, populations and methods. In label trials, the top-dose groups lost 11.1% (Foundayo), 14.9% (Wegovy injection) and 20.9% (Zepbound) of body weight, versus 2.1% to 3.1% with placebo. Individual response, other conditions and tolerability matter, and a clinician weighs them [1][6][10].
Are compounded GLP-1 drugs FDA-approved?
No. The FDA states that compounded drugs are not FDA-approved and that the agency does not review them for safety, effectiveness or quality before they are marketed. It had received 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide as of May 31, 2026 [16].

Sources

  1. FOUNDAYO (orforglipron) tablets, prescribing information (revised 7/2026). Eli Lilly and Company, 2026. uspl.lilly.com/foundayo/foundayo.html
  2. FDA approves Lilly's Foundayo (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions. Eli Lilly and Company (press release), 2026. investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-foundayotm-orforglipron-only-glp-1-pill
  3. WEGOVY (semaglutide) injection and tablets, prescribing information (revised 6/2026). DailyMed, U.S. National Library of Medicine, 2026. dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b&type=display
  4. Wegovy pill FDA approval. Novo Nordisk (company announcement), 2025. www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916472
  5. Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity (OASIS 4). New England Journal of Medicine, 2025. www.ovid.com/journals/nejm/fulltext/10.1056/nejmoa2500969~oral-semaglutide-at-a-dose-of-25-mg-in-adults-with
  6. WEGOVY (semaglutide) injection, original prescribing information (revised 06/2021). U.S. Food and Drug Administration, 2021. www.accessdata.fda.gov/drugsatfda_docs/label/2021/215256s000lbl.pdf
  7. NDA 215256 approval letter, Wegovy (semaglutide) injection, June 4, 2021. U.S. Food and Drug Administration, 2021. www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215256Orig1s000ltr.pdf
  8. Wegovy HD (semaglutide 7.2 mg) approved in the US, providing 20.7% mean weight loss. Novo Nordisk (company announcement), 2026. www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916516
  9. FDA Approves Lilly's Zepbound (tirzepatide) for Chronic Weight Management. Eli Lilly and Company (press release), 2023. investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-zepboundtm-tirzepatide-chronic-weight
  10. ZEPBOUND (tirzepatide) prescribing information (revised 8/2026). DailyMed, U.S. National Library of Medicine, 2026. dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b&type=display
  11. Novo Nordisk files for FDA approval of CagriSema. Novo Nordisk (company announcement), 2025. www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916470&embed=true
  12. Novo Nordisk Q2 2026 full presentation. Novo Nordisk (investor materials), 2026. www.novonordisk.com/content/dam/nncorp/global/en/investors/pdfs/financial-results/2026/Q2-2026-Full%20presentation.pdf
  13. Lilly's triple agonist, retatrutide, delivered powerful weight loss in pivotal Phase 3 obesity trial (TRIUMPH-1). Eli Lilly and Company (press release), 2026. investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss
  14. Lilly's triple agonist, retatrutide, successful in two additional Phase 3 obesity trials (TRIUMPH-2 and TRIUMPH-3). Eli Lilly and Company (press release), 2026. investor.lilly.com/node/54736
  15. Prescription Medications to Treat Overweight and Obesity. National Institute of Diabetes and Digestive and Kidney Diseases (NIH), 2024. www.niddk.nih.gov/health-information/weight-management/prescription-medications-treat-overweight-obesity
  16. FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. U.S. Food and Drug Administration, 2026. www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
General information, not medical advice. Results vary and treatment depends on evaluation by a licensed clinician. This article was prepared by the Healthy Weight Loss 4 U Clinical Content Team from the published sources listed above. Nothing here is a recommendation for a specific person, and no treatment is started without an evaluation by a licensed clinician.

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