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

In this article
What Is Saxenda, and Where Does It Stand Today?
Saxendais a liraglutide medicine injected under the skin once daily, belonging to the GLP-1 receptor agonistclass. It was the first GLP-1 agent authorized for weight management: the United States Food and Drug Administration (FDA) approved it on December 23, 2014, followed by the European Commission on March 23, 2015. The same molecule is used to treat type 2 diabetes at doses up to 1.8 mg daily under the name Victoza ; Saxenda instead has a daily target dose of 3.0 mg.
- Saxenda requires daily injections and produces average weight loss over 56 weeks of around 8% ; it is an obesity medicine.
- It is authorized and marketed in Türkiye (August 31, 2026 list: a box of 3 pens costs 6,729.07 TL), but is not reimbursed by SGK.
- The FDA on January 13, 2026issued a safety notification including Saxenda, requesting removal from GLP-1 medicines of removal of the warning about suicidal thoughts/behavior ; this section was removed from Saxenda's label on February 25, 2026.
- Novo Nordisk announced its decision to discontinue Saxenda in the United States market ; final shipments are planned for the end of January 2027 . The company stated that this is not a safety issue, but a portfolio decision. European and Turkish authorizations remain valid.
- In a direct comparative trial (STEP 8), weekly semaglutide 2.4 mg was markedly superior to liraglutide for weight loss: 15.8% versus 6.4%.
- Oncology considerations: the boxed warning concerns thyroid C-cell tumors in rats/mice; medullary thyroid cancer history or MEN2 syndrome are absolute contraindications.
Mechanism of Action: Why Does It Cause Weight Loss?
Liraglutide has 97% similarity to human GLP-1; adding a fatty-acid chain enables albumin binding and extends the half-life from the few minutes of natural GLP-1 to approximately 13 hours . Weight loss results from three separate mechanisms:
| Mechanism | Site | Clinical effect |
|---|---|---|
| Appetite suppression | Hypothalamus (arcuate nucleus), brainstem | Reduced hunger, earlier satiety |
| Slower gastric emptying | Stomach | Feeling full with smaller portions; also a source of nausea |
| Glucose-dependent insulin secretion and glucagon suppression | Pancreatic islets | Blood glucose control; low hypoglycemia risk when used alone |
Who Can Receive It? Indications
Adults
- BMI ≥ 30 kg/m² (obesity), or
- BMI ≥ 27 kg/m² (overweight) and at least one weight-related comorbidity: hypertension, type 2 diabetes, dyslipidemia, or obstructive sleep apnea
Adolescents (ages 12-17)
The FDA on December 4, 2020approved the obesity indication for adolescents aged 12 and older. Requirements: a percentile corresponding to an adult BMI equivalent of ≥30 kg/m² and body weight > 60 kg.
Children (ages 6-11)—Europe only
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on May 22, 2025issued a positive opinion on extending use to ages 6-11, and this age range was added to the EU SmPC. The basis was the New England Journal of Medicinepublication in 2024 of SCALE Kids (n=82; BMI change -5.8% with liraglutide and +1.6% with placebo; difference 7.4 points, p<0.001). The FDA has not approved this age group; the current United States label still states "age 12 and older."
Dosing Schedule: Weekly Steps Up to 3.0 mg
Saxenda is started at a low dose and increased in weekly steps. The sole purpose is to keep gastrointestinal side effects tolerable. Starting at 3.0 mg on the first day makes nausea and vomiting almost inevitable.
| Week | Daily dose | Number of pen "clicks" | Note |
|---|---|---|---|
| Week 1 | 0.6 mg | 1 unit | Starting dose; not a therapeutic dose |
| Week 2 | 1.2 mg | 2 units | |
| Week 3 | 1.8 mg | 3 units | Equivalent to Victoza's maximum dose |
| Week 4 | 2.4 mg | 4 units | |
| Week 5 onward | 3.0 mg | 5 units | Target maintenance dose |
If a dose is missed
- If remembered on the same day: administer it when remembered.
- If not remembered until the next day: skip the missed dose and continue with the usual dose the next day. Do not double the dose to make up for it.
- If the interruption exceeds 3 days: the medicine is restarted at 0.6 mg and titration begins again from the start. This is the most frequently overlooked rule; returning directly to 3.0 mg after a long interruption causes severe nausea and vomiting.
Practical administration
- Administer a single dosedaily, at any time of day , independently of meals. What matters is using it at the same time each day.
- Sites: abdomen, front of the thigh, outer upper arm. Rotate the injection site each time.
- Unopened pens are refrigerated (2-8°C), without freezing. After first use, the pen can be stored below 30°C or refrigerated for 1 month ; keep the cap on and protect from light.
- For every injection, use a new needle . Perform a flow check on first use.
Price, Authorization, and Reimbursement in Türkiye
| Heading | Information |
|---|---|
| Product | Saxenda 6 mg/mL solution for SC injection in a prefilled pen, 3 × 3 mL |
| Barcode | 8699676950164 |
| Retail price | 6,729.07 TL (including VAT) |
| Price-list date | August 31, 2026 Drug Price List |
| Marketing authorization holder | Novo Nordisk Sağlık Ürünleri Tic. Ltd. Şti. |
| ATC code | A10BJ02 |
| Prescription category | Standard (white) prescription |
| SGK reimbursement | Not reimbursed. In Türkiye, GLP-1 agents indicated for obesity are excluded from reimbursement; the patient pays the full drug cost. |
| Market status | Listed among active products; on sale |
How Much Weight Loss? The Actual Numbers from the SCALE Program
Saxenda's approval is based on a study program collectively called SCALE , consisting of phase 3 trials. Its results are more modest than claims often heard about "weight-loss injections."
SCALE Obesity and Prediabetes (NEJM 2015)
The largest trial in the program: 3,731 participants, 2:1 randomization, 56 weeks. Mean baseline weight was 106.2 kg and mean BMI was 38.3.
| Endpoint | Liraglutide 3.0 mg | Placebo |
|---|---|---|
| Average weight loss | 8.0% (8.4 kg) | 2.6% (2.8 kg) |
| Participants losing ≥5% | 63.2% | 27.1% |
| Participants losing >10% | 33.1% | 10.6% |
| Discontinuation due to side effects | 9.9% | 3.8% |
| Gallbladder event | 2.5% | 1.0% |
Other SCALE studies
| Study | Population (n) | Main result |
|---|---|---|
| SCALE Diabetes JAMA 2015 |
846 people with type 2 diabetes | Weight loss at 56 weeks: with 3.0 mg, 6.0%; with 1.8 mg, 4.7%; with placebo, 2.0%. Participants losing ≥5%: 54.3% / 40.4% / 21.4%. Weight loss is smaller in people with diabetes. |
| SCALE Maintenance Int J Obes 2013 |
People who had already lost 6% through diet | Over 56 weeks after randomization, an additional 6.2%was lost, versus 0.2%. Those maintaining their weight loss: 81.4%versus 48.9%. |
| SCALE Sleep Apnea Int J Obes 2016 |
359 people with moderate to severe obstructive sleep apnea | Apnea-hypopnea index at 32 weeks: -12.2versus -6.1 events/hour (p=0.015); weight loss: 5.7% versus 1.6%. |
| SCALE Teens NEJM 2020 |
251 adolescents aged 12-17 | Difference in BMI standard deviation score: -0.22 (p=0.002); weight difference: -4.50 kg. BMI reduction ≥5%: 43.3% versus 18.7%. During the 26 weeks after discontinuation, BMI z-score rose more in the liraglutide arm (difference +0.15). |
| 3-year extension Lancet 2017 |
2,254 people with prediabetes, 160 weeks | Development of type 2 diabetes: 1.8% versus 6.2% (HR 0.21; 95% CI 0.13-0.34). Weight loss at week 160: 6.1% versus 1.9%. |
Comparison with Semaglutide: The STEP 8 Trial
Liraglutide 3.0 mg was compared directly with weekly semaglutide 2.4 mg (Wegovy). JAMApublished in 2022 the STEP 8 trial, which followed 338 people for 68 weeks.
A second finding may be even more striking: treatment discontinuation was more than twice as common in the liraglutide arm —27.6% versus 13.5%. Although gastrointestinal side-effect rates were almost identical in the two arms (82.7% versus 84.1%), daily injections were much harder to sustain than weekly injections.
Does Weight Return After Discontinuation?
Yes. This is a reality for the entire GLP-1 class and must be discussed. BMJA systematic review and meta-analysis published in 2026 reported that, after stopping incretin-based medicines, an average of 6.0 kg was regained in the first year (mean loss during active treatment was 14.7 kg). Regain is faster after semaglutide and tirzepatide, with return to baseline weight in approximately 1.5 years observed.
The clearest randomized evidence specific to liraglutide is the treatment-free follow-up in SCALE Teens: after discontinuation, over 26 weeks , BMI z-score in the previously liraglutide-treated group increased significantly more than in the placebo group (difference +0.15; 95% CI 0.07-0.23).
Side Effects: Actual Rates from the Label
The rates below come from pooled adult trials involving 3,384 Saxenda and 1,941 placebo patients.
| Side effect | Saxenda | Placebo |
|---|---|---|
| Nausea | 39.3% | 13.8% |
| Diarrhea | 20.9% | 9.9% |
| Constipation | 19.4% | 8.5% |
| Vomiting | 15.7% | 3.9% |
| Headache | 13.6% | 12.6% |
| Indigestion | 9.6% | 2.7% |
| Fatigue | 7.5% | 4.6% |
| Dizziness | 6.9% | 5.0% |
| Abdominal pain | 5.4% | 3.1% |
| Increased lipase | 5.3% | 2.2% |
| Discontinuation due to side effects | 9.8% | 4.3% |
Less common but more serious events
| Event | Saxenda | Placebo | Comment |
|---|---|---|---|
| Gallstones (cholelithiasis) | 2.2% | 0.8% | Rapid weight loss itself can cause gallstones; the effect is partly weight-loss related |
| Gallbladder inflammation | 0.8% | 0.4% | Severe right upper abdominal pain requires urgent assessment |
| Acute pancreatitis (confirmed by an independent committee) | 0.3% (9/3,291) | 0.1% (2/1,843) | For severe abdominal pain radiating to the back, the medicine is stopped immediately |
| Increased heart rate | An average of 2-3 beats/min; 34% had an increase exceeding 10 beats/min | 19% | Discontinue for persistent tachycardia |
| Hypoglycemia (in people with type 2 diabetes taking a sulfonylurea) | 28.2% | 12.7% | The sulfonylurea dose must be reduced in advance . |
Liraglutide caused thyroid C-cell tumors in rats and mice, depending on dose and treatment duration. Whether this finding applies to humans is unknown. For people with a personal or family history of medullary thyroid carcinoma (MTC) , and for those with Multiple Endocrine Neoplasia type 2 (MEN2) syndrome, Saxenda is contraindicated. Report a neck mass, difficulty swallowing, shortness of breath, or persistent hoarseness. The value of routine calcitonin monitoring or thyroid ultrasound for early detection is uncertain, and neither is recommended.
Two changes in 2026
2. The preoperative approach changed. Joint guidance from AGA, ASMBS, ASA, ISPCOP, and SAGES (Clinical Gastroenterology and Hepatology, published online October 29, 2024) softened the previous advice to "stop the medicine before surgery": GLP-1 treatment may continue before surgery in patients without high aspiration risk. The precaution is a clear-liquid diet for at least 24 hoursbefore the procedure. High-risk patients include those escalating doses, on the maximum dose, with active nausea, vomiting, bloating, or reflux, and those with gastroparesis/Parkinson's disease. Gastric ultrasound or rapid-sequence induction is considered in this group. Always tell your anesthesia team that you use a GLP-1 medicine.
Contraindications and Warnings
Must not be used
- Personal or family history of medullary thyroid carcinoma .
- MEN2 syndrome
- Liraglutide or excipient hypersensitivity
- Pregnancy —discontinue immediately when pregnancy is identified. Animal studies demonstrated teratogenic effects. Women planning pregnancy should stop the medicine at least one month before the planned pregnancy.
Use with caution
| Condition | Approach |
|---|---|
| History of pancreatitis | Limited data; generally avoided |
| Gallbladder disease | Recognize the increased risk and educate the patient about symptoms |
| Renal impairment | The label does not specify a dose adjustment; however, in mild, moderate, and severe impairment and end-stage renal disease, experience is limited. Volume depletion from vomiting/diarrhea causing acute kidney injury is addressed in a separate warning. |
| Hepatic impairment | Experience is limited; use with caution . |
| Gastroparesis, severe gastrointestinal disease | Gastric emptying is already delayed; not recommended |
| Heart failure (NYHA IV) | No experience; not recommended |
| Breastfeeding | Transfer into human milk is unknown; in rat milk, concentrations are ~50% of maternal plasma levels. Decide by weighing breastfeeding benefits against the mother's needs. |
| Thyroid nodule/goiter | A simple nodule is not a contraindication; however, always ask about MTC history and MEN2 |
Interactions
- Sulfonylureas and insulin: markedly increase hypoglycemia risk. When adding Saxenda, their doses are reduced in advance and blood glucose is monitored closely.
- Absorption of oral medicines: delayed gastric emptying may alter the rate of absorption. Clinically meaningful interactions have not been demonstrated for most medicines; however, for medicines with a narrow therapeutic range (warfarin, levothyroxine, digoxin), caution and appropriate monitoring (INR, TSH) at treatment initiation and dose changes are advisable.
- Oral contraceptives: No clinically meaningful reduction in effectiveness has been reported.
- Other GLP-1 agonists and DPP-4 inhibitors: Do not combine; there is no additional benefit and side effects increase.
- Alcohol: Limit intake because of hypoglycemia and pancreatitis risk.
Pharmacokinetic Summary
| Parameter | Value |
|---|---|
| Absolute bioavailability (subcutaneous) | ~55% |
| Time to peak plasma level (Tmax) | ~11 hours |
| Plasma protein binding | >98% |
| Volume of distribution | ~20-25 L |
| Half-life | ~13 hours (allows once-daily dosing) |
| Clearance | ~0.9-1.4 L/hour |
| Metabolism | Broken down endogenously like a large protein, through DPP-4 and neutral endopeptidase . No particular organ is the main elimination route; unchanged drug in urine and feces is minimal. |
An Oncology Perspective: What Do We Know About Cancer?
After smoking, obesity is now among the leading preventable causes of cancer . At least 13 cancer types are linked to excess weight: endometrial, esophageal adenocarcinoma, gastric cardia, liver, kidney, pancreatic, colorectal, gallbladder, ovarian, breast (postmenopausal), thyroid, multiple myeloma, and meningioma. Any effective weight-loss treatment therefore has theoretical relevance to cancer risk.
- No randomized trial has shown that GLP-1 agents reduce cancer risk. Current data come from observational cohorts and suggest reduced obesity-associated cancer risk, but causality has not been established.
- Thyroid cancer: The boxed warning is based on rodent data. No signal for medullary thyroid cancer has been demonstrated in humans. Some observational studies reported a weak association with papillary thyroid cancer, but larger, better-designed analyses did not confirm it.
- Pancreatic cancer: Long debated because of increased pancreatitis risk; accumulated evidence does not support an increased pancreatic cancer risk.
- Use in patients with cancer: Data on the safety and benefit of GLP-1 agents during active cancer treatment are almost nonexistent. Nausea, loss of appetite, and weight loss are already common problems during cancer therapy; adding these agents may worsen unwanted weight loss and muscle loss. Decisions must therefore be made with the oncologist on a case-by-case basis.
We discuss new data on weight-loss injections in breast cancer survivors in a separate article; for details of the relationship between obesity and cancer, see the obesity-cancer relationship article.
Saxenda's Future: Discontinuation in the United States
In August 2026, Novo Nordisk announced that it would discontinue Saxenda supply in the United States market . Final shipments to wholesalers are planned for the end of January 2027 . The company's statement is clear: this is a "strategic portfolio decision"and "is not due to any safety or quality concerns". It cited the arrival of newer medicines and a steadily declining number of Saxenda users; the company is shifting its focus to Wegovy (pen and oral forms).
| Region | Status (September 4, 2026) |
|---|---|
| United States | Originator Saxenda is being discontinued; final shipments at the end of January 2027. Generic liraglutide (Teva, FDA approval and market launch on August 28, 2025) remains on sale. |
| European Union | Authorization remains valid. The supply shortages in 2023-2024 were closed by the EMA on September 2, 2026 as resolved . |
| Türkiye | Authorized and on sale; included in the active-product price list. Novo Nordisk Türkiye has made no announcement about Saxenda's future. |
Frequently Asked Questions
- Are Saxenda and Victoza the same medicine?
- The active ingredient is the same (liraglutide); the dose and indication differ. Victoza is used for type 2 diabetes at up to 1.8 mg daily, while Saxenda is used for weight management at up to 3.0 mg. They must not be used together.
- Which is better: Saxenda, Wegovy, or Mounjaro?
- Current evidence ranks weight-loss efficacy as follows: tirzepatide > semaglutide > liraglutide. In STEP 8, semaglutide 2.4 mg outperformed liraglutide 3.0 mg: 15.8% versus 6.4%. For details, see our semaglutide and tirzepatide articles. However, the "best medicine" is determined by considering access, tolerability, comorbidities, and cost together.
- How long does nausea last?
- Nausea occurs most often during dose-escalation weeks and, in most patients, decreases within a few weeks. Helpful measures include smaller portions, avoiding fatty and fried foods, eating slowly, stopping at the first sign of fullness, and taking small, frequent amounts of fluid. If nausea is intolerable, dose escalation is delayed for one week.
- Does it work without dieting?
- In every trial, both arms received a reduced-calorie diet and increased physical activity. Thus, the 8% weight loss reflects "medicine + lifestyle", rather than the medicine alone. Protein intake and resistance exercise are also critical to preserving muscle; a substantial part of rapid weight loss may be muscle.
- How long is it used?
- Indefinitely, if effective and tolerated; obesity is a chronic disease. However, discontinue if 5% of baseline weight has not been lost after 12 weeks at 3.0 mg (Türkiye/EU rule).
- I do not have diabetes. Could my blood glucose fall?
- The insulin-stimulating effect of GLP-1 is glucose-dependent: it does not stimulate insulin release when blood glucose is normal. Hypoglycemia risk is therefore low when used alone. Risk rises markedly with sulfonylureas or insulin in combination.
- I am having surgery. Should I stop it?
- Joint guidance after 2024 states that patients without high aspiration risk may continue treatment without interruptionand should follow a clear-liquid diet for at least 24 hours before the procedure. Decide with the anesthesia team; always report that you use a GLP-1 medicine.
- I have a thyroid nodule. Can I use it?
- A simple thyroid nodule alone is not a contraindication. Contraindications are a personal or family history of medullary thyroid carcinoma and MEN2 syndrome. Both must be checked before starting treatment.
- Will weight return when I stop?
- Most likely, yes. A 2026 BMJmeta-analysis showed that an average of 6.0 kg was regained in the first year after stopping incretin medicines. This reflects the chronic nature of the disease, rather than failure of the medicine.
- Does Saxenda cause cancer?
- Human data provide no evidence that Saxenda causes cancer. The boxed warning is based on thyroid C-cell tumors in rats and mice, and whether this applies to humans is unknown. By contrast, obesity itself is an established risk factor for at least 13 cancer types.
- Saxenda (liraglutide) US Prescribing Information, Novo Nordisk; revised 6/2026 (DailyMed).
- FDA Approval Letter, NDA 206321/S-025, February 25, 2026.
- FDA Drug Safety Communication: "FDA Requests Removal of Suicidal Behavior and Ideation Warning from GLP-1 Receptor Agonist Medications", January 13, 2026.
- Saxenda EPAR and Summary of Product Characteristics, European Medicines Agency (EMA); variation II-42, CHMP positive opinion May 22, 2025.
- Pi-Sunyer X, et al. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med 2015;373:11-22 (SCALE Obesity and Prediabetes).
- Davies MJ, et al. Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes. JAMA 2015;314:687-99 (SCALE Diabetes).
- Wadden TA, et al. Weight maintenance and additional weight loss with liraglutide. Int J Obes 2013;37:1443-51 (SCALE Maintenance).
- Blackman A, et al. Effect of liraglutide 3.0 mg in individuals with obesity and moderate or severe obstructive sleep apnea. Int J Obes 2016;40:1310-19.
- Kelly AS, et al. A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity. N Engl J Med 2020;382:2117-28 (SCALE Teens).
- Fox CK, Arslanian S, et al. Liraglutide for Children 6 to <12 Years of Age with Obesity. N Engl J Med 2024 (SCALE Kids).
- le Roux CW, et al. 3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes. Lancet 2017;389:1399-1409.
- Rubino DM, et al. Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes. JAMA 2022;327:138-150 (STEP 8).
- West S, et al. Weight regain after cessation of medication for weight management: systematic review and meta-analysis. BMJ 2026;392:e085304.
- Multisociety Clinical Practice Guidance for the Safe Use of GLP-1 Receptor Agonists in the Perioperative Period. Clin Gastroenterol Hepatol, published online October 29, 2024 (AGA, ASMBS, ASA, ISPCOP, SAGES).
- EMA PRAC: NAION classified as a very rare side effect for semaglutide products, June 6, 2025; MHRA Drug Safety Update, February 5, 2026.
- T.C. Sağlık Bakanlığı İlaç Fiyat Listesi, August 31, 2026.
- Teva Pharmaceutical Industries, generic liraglutide (Saxenda generic) FDA approval and market launch, August 28, 2025.
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