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Prof. Dr. Mustafa Özdoğan · Medical Oncologist

What Is Wegovy? FDA Approval, Turkish Authorization, Price, and Reimbursement Status

What Is Wegovy? FDA Approval, Turkish Authorization, Price, and Reimbursement Status
In this article

Brief Summary

  • What is it? Wegovy (semaglutide) is a GLP-1 receptor agonist given once weekly by subcutaneous injection for weight management. It contains the same active ingredient as Ozempic; the difference is the dose (up to 2.4 mg).
  • How much weight loss? In adults without diabetes, an average over 68 weeks of 14.9% (STEP 1). But this figure does not apply to everyone: in type 2 diabetes, 9.6%; in the SELECT population with heart disease, 9.4%.
  • What happens after stopping? In the STEP 1 extension, within 1 year after discontinuation, approximately two-thirds of the lost weight was regained. This is ongoing treatment, rather than a finite course.
  • In Türkiye: An imported product authorized by Novo Nordisk and sold with a white prescription—it does not require overseas procurement. SGK does not reimburse it. 2.4 mg pen: 15,990 TL (August 31, 2026 list).
  • Three developments since 2024: MASH (fatty liver disease) indication (August 15, 2025), oral Wegovy 25 mg tablets (December 22, 2025), and high-dose Wegovy HD 7.2 mg (March 19, 2026).
  • Two important safety updates: In Europe, NAION (optic nerve damage that can cause sudden vision loss) was added to the label as a very rare side effect (June 2025). Conversely, the FDA removed the suicidal-thoughts warning (January 13, 2026)—its review found no increased risk.
  • The preoperative rule changed: Since October 2024, stopping the medicine in most patients is not recommended; a 24-hour liquid diet is recommended only for high-risk patients.

What Is Wegovy? Why Does It Matter?

Wegovy is the semaglutide high-dose formulation developed to treat obesity. The same molecule is marketed for type 2 diabetes under the name Ozempic at lower doses. The difference is the dose: Ozempic reaches a maximum of 2 mg, whereas Wegovy is titrated to 2.4 mg (and, from 2026, 7.2 mg).

It matters for two reasons. First, it delivers an unprecedented level of efficacy in obesity treatment, with weight loss approaching bariatric surgery. Second, and perhaps more importantly, it has been shown to improve hard clinical outcomes as well as weight: in the 17,604-patient SELECT trial, it reduced the risk of heart attack, stroke, and cardiovascular death by 20%.

Mechanism of Action

GLP-1 (glucagon-like peptide-1) is a natural hormone released by the intestine after eating. Semaglutide is a long-acting mimic and acts at four sites:

Site of action What does it do?
Pancreas Increases insulin secretion and suppresses glucagon when blood glucose is high. Because the action is glucose-dependent , it does not cause hypoglycemia on its own.
Stomach Slows gastric emptying, prolonging fullness. This also causes nausea and bloating.
Brain (hypothalamus) Stimulates satiety centers, reducing hunger and "food thoughts." This is the change patients describe most often.
Cardiovascular system It is thought to reduce vascular inflammation independently of weight loss; SELECT's entire benefit cannot be explained by weight loss.

The design enabling once-weekly dosing

Natural GLP-1 has a half-life of a few minutes. The fatty-acid side chain added to semaglutide enables more than 99% albumin binding in the blood, protecting it from breakdown and extending its half-life to approximately 1 week . Once-weekly injections result from this design.

Approval Process—Timeline

Date Development
June 4, 2021 FDA approval—chronic weight management in adults (BMI ≥30, or BMI ≥27 + at least one comorbidity)
January 6, 2022 European (EMA) approval— adolescent indication included from the outset (age ≥12, weight >60 kg)
December 23, 2022 FDA—obesity in adolescents aged 12 and older
March 8, 2024 FDA— cardiovascular risk reduction (established cardiovascular disease + obesity/overweight). Based on SELECT.
August 15, 2025 FDA— MASH (noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate-to-advanced fibrosis). Accelerated approval; ESSENCE trial.
December 22, 2025 FDA— Wegovy tablets (oral semaglutide 25 mg). The first oral GLP-1 for weight management.
March 19, 2026 FDA— Wegovy HD 7.2 mg injection. Only for adult obesity after tolerating 2.4 mg for at least 4 weeks.
May 21-22, 2026 Europe—CHMP positive opinion for oral semaglutide tablets

Unapproved uses—do not confuse these

Some Wegovy trials were positive but did not become approved indications: knee osteoarthritis (STEP 9—substantial pain reduction), heart failure with preserved ejection fraction (STEP-HFpEF), and peripheral arterial disease (STRIDE—conducted with Ozempic, not a Wegovy indication). Wegovy use for these conditions is off-label.

How Much Weight Loss?

STEP 1: proportion achieving target weight loss at 68 weeks
1,961 adults without diabetes; semaglutide 2.4 mg versus placebo
≥5% weight loss
86.4%
Placebo
31.5%
≥10% weight loss
69.1%
Placebo
12.0%
≥15% weight loss
50.5%
Placebo
4.9%
≥20% weight loss
32.0%
Placebo
1.7%
Average weight change: − 14.9% versus − 2.4% (difference −12.4 points; 95% CI −13.4 to −11.5; p<0.001). In absolute terms, −15.3 kg versus −2.6 kg.

The expectation "I will lose 15%" is not right for most patients

A common patient-counseling mistake is to assume STEP 1's 14.9% applies to everyone. The same medicine yields very different results in different groups:

Average weight loss with semaglutide 2.4 mg—by population
Same dose, different patient groups
STEP 1 —obesity without diabetes
14.9%
STEP 5 —104 weeks
15.2%
STEP 2 —with type 2 diabetes
9.6%
SELECT —with heart disease
9.4%
Wegovy HD 7.2 mg (STEP UP)
20.7%
Bars use a 20% scale. Weight loss is substantially smaller in people with type 2 diabetes —the most important figure for managing expectations. STEP 5 showed that weight loss plateaued around week 60 and was maintained for 2 years.

Comparison with tirzepatide (SURMOUNT-5)

In a direct comparison of 751 patients over 72 weeks, tirzepatide (Mounjaro) produced − 20.2%, while semaglutide produced − 13.7% weight loss (p<0.001). Waist reduction was −18.4 cm versus −13.0 cm. Thus, tirzepatide was superior in this comparison. Discontinuation for gastrointestinal reasons was 5.6% with semaglutide and 2.7% with tirzepatide. Patients will ask about this comparison; this is the honest answer.

What Happens When You Stop?

⅔
Proportion of lost weight regained within 1 year of discontinuationIn the STEP 1 extension (327 patients), by week 68 patients had lost an average of 17.3% . Over the 52 weeks after stopping, 11.6 percentage points were regained , leaving a net loss at week 120 of 5.6%. Improvements in blood pressure, cholesterol, and blood glucose also largely returned to baseline.

STEP 4 independently confirmed this: patients switched to placebo at week 20 gained, over the following 48 weeks, 6.9%, while those continuing the medicine lost an additional 7.9%.

What this means

Wegovy is ongoing treatment rather than a finite course —like blood pressure or cholesterol medication. According to the evidence, a plan to "stop once I reach my target" leads to regain of much of the lost weight. The prescribing information contains no discontinuation or tapering schedule. This must be discussed before starting, particularly in Türkiye, where the medicine is not reimbursed and the patient pays the entire cost.

Cardiovascular Benefit: The SELECT Trial

This is the most important evidence distinguishing Wegovy from other weight-loss medicines. 17,604 patients (older than 45, BMI ≥27, with previous heart attack/stroke/peripheral arterial disease and without diabetes) were followed for an average of 40 months .

Endpoint Semaglutide Placebo Hazard ratio
Primary endpoint (MACE) 6.5% 8.0% 0.80 (95% CI 0.72-0.90; p<0.001)
Nonfatal heart attack 2.7% 3.7% 0.72 (0.61-0.85)
All-cause death 4.3% 5.2% 0.81 (0.71-0.93)
Cardiovascular death 2.5% 3.0% 0.85 (0.71-1.01)— not significant

Note: discontinuation due to side effects in this study was 16.6% versus 8.2% —a more realistic estimate for real-world discontinuation than STEP 1's 6.8%.

Dosing Schedule and Administration

Injectable form—gradual dose escalation

Week Dose (1 dose weekly, subcutaneous) Note
1-4 0.25 mg Not a therapeutic dose; allows the body to adjust
5-8 0.5 mg Gradual escalation to reduce nausea
9-12 1 mg
13-16 1.7 mg Final step before maintenance
17 onward 2.4 mg (recommended)
or 1.7 mg
If 2.4 mg is not tolerated, 1.7 mg may continue as the maintenance dose

What if the dose is not tolerated?

The prescribing information states: "Consider delaying dose escalation for 4 weeks." The schedule is therefore flexible; a step may last longer if nausea is troublesome. Total titration lasts 16 weeks and must not be shortened; rapid escalation is the most common cause of gastrointestinal side effects.

Missed dose—the precise rule

  • If the next scheduled dose is more than 2 days away , administer as soon as possible.
  • If the next scheduled dose is less than 2 days away , skip the missed doseand continue on your usual day.
  • If 2 or more consecutive doses are missed, treatment may resume as scheduled; if necessary, the physician may restart titration from the beginning.

The injection day can change, provided at least 48 hours have elapsed since the last dose.

New formulations

Wegovy tablets (oral 25 mg)
Once daily by mouth. Schedule: days 1-30, 1.5 mg → days 31-60, 4 mg → days 61-90, 9 mg → from day 91, 25 mg. A missed tablet is skipped; continue the usual dose the next day. In OASIS 4, mean weight loss was 16.6% at 64 weeks.
Wegovy HD 7.2 mg
Only for adult obesity and after tolerating 2.4 mg for at least 4 weeks. Not used in adolescents. In STEP UP, weight loss was 20.7% at 72 weeks. Note: at this dose, dysesthesia (burning/tingling skin) was reported in 22% of patients (6% at 2.4 mg).
Switching from other GLP-1 medicines
The prescribing information describes only switching between Wegovy injections and Wegovy tablets . No labeled schedule exists for switching from Ozempic, Mounjaro, or Saxenda; such a switch is off-label and requires a physician's decision.

Administration and storage

Topic Information
Pen type (Türkiye/Europe) FlexTouch multidose pen —a monthly box contains 1 pen. Needles are obtained separately (NovoFine Plus, NovoFine, or NovoTwist; maximum 8 mm). Different from the single-use pens in the United States.
Injection site Abdomen, thigh, or upper arm. Approximately 5 cm from the navel. Site and timing may change freely without dose adjustment. Do not repeatedly inject into the same spot.
Storage (unopened) Refrigerate at 2-8 °C, away from the cooling element. Do not freeze.
After opening European/Turkish pen: for up to 6 weeks below 30 °C or refrigerated.
Renal impairment No dose adjustment for eGFR ≥30 mL/min. No data for values below 30. In severe nausea, vomiting, or diarrhea, monitor for acute kidney injury due to dehydration .
Hepatic impairment No meaningful pharmacokinetic difference in mild, moderate, or severe impairment (Child-Pugh A-C).

Price, Authorization, and Reimbursement in Türkiye

Authorization status

  • Marketing authorization holder: Novo Nordisk Sağlık Ürünleri Ticaret Ltd. Şti.
  • Status: Authorized imported product (reference country: Malta). The overseas drug procurement route is not used —it is obtained normally from a pharmacy.
  • Prescription type: White prescription · ATC code: A10BJ06
  • SGK: Not reimbursed. The patient pays the full cost.
Presentation Retail price (including VAT) List date
Wegovy 0.25 mg—1 pen 10,643.48 TL August 31, 2026
Wegovy 0.5 mg—1 pen 10,643.48 TL August 31, 2026
Wegovy 1 mg—1 pen 10,643.48 TL August 31, 2026
Wegovy 1.7 mg—1 pen 14,950.00 TL August 14, 2026
Wegovy 2.4 mg—1 pen 15,990.00 TL August 31, 2026

Prices fell during 2026

Drug-price database records show that the 2.4 mg pen reached as high as 23,745 TLduring the year, averaging 18,962 TL; the 1.7 mg pen reached 18,138 TL. Current prices are therefore well below the year's peak. Every price quotation must therefore include its date and be confirmed through the pharmacy system before purchase.

Comparison (same price list) Presentation Price
Ozempic 0.25 / 0.5 / 1 mg 1 pen 10,643.48 TL
Mounjaro (tirzepatide) 2.5 mg 4 pens (1 month) 12,294.55 TL
Mounjaro 10 mg 4 pens (1 month) 21,637.94 TL
Mounjaro 15 mg 4 pens (1 month) 27,244.00 TL

Compare like with like: a Wegovy box in Türkiye contains 1 multidose pen = 1 month, while a Mounjaro box contains 4 single-dose pens = 1 month. These prices can therefore be compared as monthly costs. Zepbound is not authorized in Türkiye; tirzepatide is available only as Mounjaro.

Side Effects

Side effect Wegovy 2.4 mg Placebo
Nausea 44% 16%
Diarrhea 30% 16%
Vomiting 24% 6%
Constipation 24% 11%
Abdominal pain 20% 10%
Headache 14% 10%
Fatigue 11% 5%
Indigestion 9% 3%
Dizziness 8% 4%
Bloating / belching 7% / 7% 5% / <1%
Reflux 5% 3%

Discontinuation due to side effects: In STEP 1, 6.8% versus 3.2%. However, in SELECT, the rate was 16.6% —a realistic expectation in an older, sicker population.

Reducing gastrointestinal side effects

  • Do not accelerate titration; stay at a step for an additional 4 weeks if needed
  • Small, frequent meals; eat slowly; avoid fatty and spicy foods
  • Stop when full—gastric emptying is already delayed
  • Fluids and fiber for constipation; watch for dehydration during diarrhea/vomiting

Safety Information That Changed Between 2024-2026

This section covers three issues that older sources may describe incorrectly.

1 · NAION added (June 2025)—applicable in Türkiye

NAION (nonarteritic anterior ischemic optic neuropathy) involves reduced blood flow to the optic nerve and may cause painless, sudden vision loss . In June 2025, the EMA Pharmacovigilance Risk Assessment Committee (PRAC) recognized it as a "very rare" side effect of semaglutide-containing medicines (Ozempic, Rybelsus, Wegovy)— up to 1 in 10,000 users. European product information was updated; if NAION is confirmed, treatment must be discontinued.

Important: The FDA has not added this warning to the United States label (also absent from the June 2026 revision). Because Türkiye follows European labeling, this warning applies to our patients. Seek medical attention without delay for sudden vision loss or blurring.

2 · Suicidal-thoughts warning removed (January 13, 2026)

The concerns raised in 2023 have been resolved. The FDA reviewed 91 placebo-controlled studies (107,910 patients) in a meta-analysis and 2,243,138 users in a cohort study; for suicidal thoughts or behavior, no increased risk was found. Conclusion: "the evidence does not support a causal association." The FDA asked manufacturers to remove this warning from Saxenda, Wegovy, and Zepbound labeling. Europe's PRAC had reached the same conclusion in April 2024. The suicidal-thoughts warning in older articles is no longer current.

3 · Preoperative rule changed (October 2024)

In 2023, the American Society of Anesthesiologists recommended stopping GLP-1 medicines before surgery. Joint guidance from five societies in October 2024 changed that recommendation:

  • Most patients should continue treatment —routine discontinuation is no longer recommended
  • For high-risk patients, before the procedure, a 24-hour liquid diet
  • High-risk features include: the titration period (first 4-8 weeks), active gastrointestinal symptoms (nausea, vomiting, abdominal pain, constipation), high doses, and comorbidities that delay gastric emptying
  • For the highest-risk patients, before the procedure, gastric ultrasonography

Other important warnings

  • Acute pancreatitis —stop treatment and seek urgent assessment for severe, persistent abdominal pain. Postmarketing reports include necrotizing pancreatitis and fatal cases.
  • Gallbladder disease —gallstone and inflammation risks increase during rapid weight loss.
  • Ileus and intestinal obstruction, severe constipation, and fecal impaction have been reported after marketing.
  • Diabetic retinopathy —in type 2 diabetes, rapid glucose improvement may temporarily worsen retinopathy; eye monitoring is required.
  • Increased heart rate and hypersensitivity reactions.
  • Hypoglycemia —not caused by treatment alone, but risk increases with insulin or sulfonylureas; reduce those medicines' doses.

Boxed warning and contraindications

Boxed warning: In rodents, semaglutide causes thyroid C-cell tumors at clinically relevant exposures. The relevance to humans is unknown.

Contraindications: (1) Personal or family history of medullary thyroid cancer (MTC) or MEN 2 syndrome. (2) History of serious hypersensitivity to semaglutide or excipients.

An Oncology Perspective

Obesity is an established risk factor for at least 13 cancer types. Whether GLP-1 medicines reduce that risk is an active research area.

Cancer risk: observational data are encouraging

  • JAMA Oncology, August 2025 —86,632 matched patients: overall cancer incidence among GLP-1 users HR 0.83 (95% CI 0.76-0.91). Endometrial HR 0.75; ovarian HR 0.53; meningioma HR 0.69. For kidney cancer, HR 1.38 (not significant).
  • JAMA Network Open, 2024 —1,651,452 people with type 2 diabetes: compared with insulin , reductions in 10 of 13 obesity-associated cancers (colorectal HR 0.54; pancreas 0.41; liver 0.47). No reduction in breast or thyroid cancer.
  • ASCO 2026 —among 12,112 patients with stage I-III cancer, progression to stage IV: lung 10% versus 22%, breast 10% versus 20%, colorectal 13% versus 22%, liver 19% versus 28%.

An honest caveat: in the same 2024 study, no cancer showed a significant reduction compared with metformin —kidney cancer HR was actually 1.54. Much of the apparent benefit may therefore reflect the unfavorable comparator (insulin). No randomized trial has cancer outcomes as its endpoint. These data generate hypotheses; they do not justify treatment.

Where Do Concerns About Thyroid and Pancreatic Cancer Stand?

Thyroid: An international study across six databases (92,497 GLP-1 users) found no increased thyroid cancer risk. Follow-up, however, was only 1.8-3 years , which the American Thyroid Association considers insufficient to assess long-term risk. The accurate statement is: no human signal so far, but the issue is not settled. The boxed warning and MTC/MEN 2 contraindication remain fully in force.

Pancreas: No increased pancreatic cancer risk has been demonstrated; reductions have instead been reported. By contrast, acute pancreatitis is a real, labeled side effect. Do not confuse the two.

Muscle Loss

Some weight lost with Wegovy is muscle , rather than fat. In STEP 1's body-composition analysis, 39-40% of the lost weight was lean tissue . This falls within the 20-50% range seen with dieting or bariatric surgery—so it is not unique to GLP-1 medicines, but it is not trivial.

Reducing muscle loss (professional society recommendations)

  • Protein: daily, 1.2-1.6 g/kg, distributed across meals
  • Resistance exercise: weekly, 2-3 sessions, 30-45 minutes, using multijoint movements. This is the most effective single intervention for preserving muscle.
  • Protein alone is not enough —it does not work without resistance exercise.
  • Assessment of body composition and muscle strength is recommended before treatment.

Counterfeit product warning

The World Health Organization, on June 19, 2024 , issued a global warning about counterfeit semaglutide pens; some seized products contained no active ingredient, while others contained undeclared insulin , which may cause fatal hypoglycemia. The FDA issued separate counterfeit-batch warnings in April 2025 and December 2025. Obtain the medicine only from a pharmacy with a prescription. Do not buy online, through social media, or from channels advertising "imported" products.

Frequently Asked Questions

What is the difference between Wegovy and Ozempic?
The active ingredient is the same (semaglutide). The difference is the dose: Ozempic for type 2 diabetes reaches 2 mg, while Wegovy for obesity reaches 2.4 mg (new HD formulation: 7.2 mg). Ozempic has no weight-loss indication.
Does SGK cover it?
No. The patient pays the entire cost. Monthly maintenance cost is approximately 16,000 TL(August 2026 price).
How long must I use it?
There is no time limit, and evidence supports ongoing use. After discontinuation, approximately two-thirds of the lost weight returns within one year.
My nausea is severe. What should I do?
Do not accelerate dose escalation; after discussing it with your physician, you may remain at the current step for another 4 weeks. Smaller meals, slow eating, and avoiding fatty foods are sufficient for most patients. Severe, persistent abdominal pain is different—it requires urgent assessment for pancreatitis.
I am having surgery. Should I stop?
According to the updated joint guidance of October 2024, most patients do not need to stop. If you are titrating or have gastrointestinal symptoms, however, you are high risk; a liquid diet for 24 hours before the procedure is then recommended. Always tell the anesthesia team that you use this medicine.
My vision became blurry. Is that important?
Sudden, painless vision loss may indicate NAION, although it is very rare. Seek medical attention without delay. In addition, rapid glucose improvement in type 2 diabetes may temporarily worsen retinopathy.
I have a history of cancer. Can I use it?
For a history of medullary thyroid cancer or MEN 2, use is absolutely contraindicated. No rule prohibits use in other cancer types, but no guideline addresses use during active treatment either—decide with your oncologist.

Summary

Wegovy provides unprecedented efficacy in obesity treatment (mean 14.9% loss in adults without diabetes), and a randomized trial showed reduced heart attack, stroke, and death risk beyond weight loss. Since 2024, MASH, an oral tablet, and high-dose injections have been added.

Remember three points: (1) Expected weight loss varies by patient group—around 9-10% in diabetes. (2) This is not a finite course; two-thirds of lost weight returns after stopping, and in Türkiye the patient pays the full cost. (3) Safety information changed over the past two years: NAION was added, the suicidal warning removed, and routine preoperative discontinuation abandoned.

References
  1. FDA. WEGOVY (semaglutide) US Prescribing Information, rev. 06/2026.
  2. Wilding JPH, et al. Once-weekly semaglutide in adults with overweight or obesity (STEP 1). N Engl J Med 2021;384:989-1002.
  3. Wilding JPH, et al. Weight regain and cardiometabolic effects after withdrawal of semaglutide: the STEP 1 trial extension. Diabetes Obes Metab 2022;24:1553-1564.
  4. Rubino D, et al. Effect of continued weekly subcutaneous semaglutide vs placebo on weight loss maintenance (STEP 4). JAMA 2021;325:1414-1425.
  5. Davies M, et al. Semaglutide 2.4 mg in adults with overweight or obesity and type 2 diabetes (STEP 2). Lancet 2021;397:971-984.
  6. Lincoff AM, et al. Semaglutide and cardiovascular outcomes in obesity without diabetes (SELECT). N Engl J Med 2023;389:2221-2232.
  7. Aronne LJ, et al. Tirzepatide vs semaglutide once weekly in obesity (SURMOUNT-5). N Engl J Med 2025.
  8. Weghuber D, et al. Once-weekly semaglutide in adolescents with obesity (STEP TEENS). N Engl J Med 2022;387:2245-2257.
  9. Newsome PN, et al. Semaglutide in metabolic dysfunction-associated steatohepatitis (ESSENCE). N Engl J Med 2025.
  10. European Medicines Agency / PRAC. Semaglutide-containing medicines and NAION—product information update, June 2025. WHO announcement
  11. FDA. FDA requests removal of suicidal behavior and ideation warning from GLP-1 receptor agonist labels. January 13, 2026. fda.gov
  12. ASA et al. Multi-society clinical practice guidance for the perioperative management of GLP-1 receptor agonists. October 2024. asahq.org
  13. Dai H, et al. GLP-1 receptor agonists and cancer risk in adults with overweight or obesity. JAMA Oncol 2025.
  14. Wang L, et al. GLP-1 receptor agonists and obesity-associated cancers in patients with type 2 diabetes. JAMA Netw Open 2024.
  15. World Health Organization. Medical Product Alert N°2/2024—falsified semaglutide products. June 19-20, 2024.

Transparency note

Turkish prices were confirmed through three independent databases reflecting TİTCK's reference price list (August 31, 2026 list); because direct TİTCK access was unavailable, the authorization number and date could not be verified and were not included. As the Turkish SmPC had not yet been published in the relevant databases, dose, storage, and side-effect information came from European product information; the number of doses in the Turkish pen should be checked against the Turkish SmPC. No supply shortage or TİTCK counterfeit-product alert was found in Türkiye (absence of evidence). Prices change frequently, so check the pharmacy system before purchase.

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