What Is Trulicity? FDA Approval, Turkish Authorization, Price, and Reimbursement Status
In this article
Brief Summary
- What is it? Trulicity (dulaglutide) is a GLP-1 receptor agonist given once weekly by subcutaneous injection to treat type 2 diabetes . It is not an obesity medicine, unlike Wegovy and Saxenda.
- Which doses are available in Türkiye? Only 0.75 mg and 1.5 mg. Available in the United States and Europe, the 3.0 mg and 4.5 mg strengths are not marketed in Türkiye —the practical maximum here is therefore 1.5 mg.
- Price: Both strengths cost 13,238.20 TL (4 pens = approximately 1 month; August 31, 2026 list). At the beginning of 2026, the price was 11,518.76 TL.
- SGK does not reimburse it. The only active ingredient named for the GLP-1 group in the SUT diabetes section is exenatide; dulaglutide, liraglutide, and semaglutide do not appear in that provision.
- Cardioprotection: In REWIND (9,901 patients, 5.4 years of follow-up), it reduced major cardiovascular event risk by 12% (HR 0.88). Within the GLP-1 class, this is the only cardiovascular indication also covering primary prevention .
- Renal advantage: No dose adjustment is needed even in severe renal impairment, an important advantage over many diabetes medicines. However, European/Turkish labeling does not recommend use below eGFR 15.
- Weight effect is modest: In REWIND, mean loss was 2.95 kg. In the direct SUSTAIN 7 comparison, semaglutide produced more than twice the weight loss.
- Current note: Trulicity has not been discontinued, but the manufacturer's own supply page marks it as having "limited availability."
What Is Trulicity? Why Does It Matter?
Dulaglutideis a long-acting mimic of natural intestinal GLP-1. Trulicity is its once-weekly injectable prefilled-pen form.
It differs from other GLP-1 medicines in two ways. First, it has no obesity indication —it is approved only for type 2 diabetes (weight loss is an expected side effect, rather than the target). Second, and more importantly, its cardiovascular indication covers not only established heart disease but also people with multiple risk factors who have not yet developed heart disease. No other GLP-1 medicine has this feature.
Mechanism of Action
| Site of action | What does it do? |
|---|---|
| Pancreas | Increases insulin secretion and suppresses glucagon when glucose is high. Its action is glucose-dependent and therefore does not cause hypoglycemia alone. |
| Stomach | Slows gastric emptying, prolonging fullness; this also causes nausea and bloating. |
| Brain | Stimulates satiety centers, reducing appetite and energy intake. |
The design enabling weekly dosing: Fc fusion
Natural GLP-1 has a half-life of a few minutes. Dulaglutide is built by fusing an antibody's Fc fragment to two GLP-1 analogues. This large structure protects against enzymatic breakdown and rapid renal elimination, extending the half-life to approximately 5 days . This is a different engineering solution from semaglutide's albumin binding.
Approval Process—Timeline
| Date | Development |
|---|---|
| September 18, 2014 | FDA approval—glycemic control in type 2 diabetes, alongside diet and exercise |
| November 21, 2014 | European (EMA) approval |
| February 21, 2020 | Cardiovascular indication —"for adults with established cardiovascular disease or multiple cardiovascular risk factors and type 2 diabetes, to reduce the risk of major cardiovascular events." Based on REWIND. |
| September 3, 2020 | FDA— 3.0 mg and 4.5 mg strengths added (AWARD-11). These strengths are unavailable in Türkiye. |
| November 17, 2022 | FDA— age 10 and older pediatric type 2 diabetes indication |
| November 8, 2024 | All GLP-1 medicines received a pulmonary aspiration warning during anesthesia . |
| March 12, 2026 | Label update— severe gastrointestinal side effects, intestinal obstruction, and severe constipation added to the postmarketing section |
Evidence: The REWIND Trial
This is Trulicity's most important clinical evidence and defines its role in type 2 diabetes treatment.
| Measure | Dulaglutide 1.5 mg | Placebo | Result |
|---|---|---|---|
| Patients | 4,949 | 4,952 | Total 9,901; median follow-up 5.4 years |
| Major cardiovascular event | 12.0% | 13.4% | HR 0.88 (95% CI 0.79-0.99); p=0.026 |
| All-cause death | 10.8% | 12.0% | HR 0.90 (0.80-1.01); p=0.067— not significant |
| Composite renal endpoint | 17.1% | 19.6% | HR 0.85 (0.77-0.93); p=0.0004 |
| HbA1c change | − 0.46% | + 0.16% | — |
| Weight change | −2.95 kg | −1.49 kg | Net difference approximately 1.5 kg |
| Gastrointestinal side effects | 47.4% | 34.1% | p<0.0001 |
Two features make REWIND distinctive
1 · Primary prevention. Approximately 69% of patients had no established cardiovascular disease —only risk factors. Other GLP-1 cardiovascular trials largely involved established heart disease. This explains the "multiple risk factors" wording in Trulicity's indication.
2 · Baseline HbA1c was low (median 7.2%). The cardiovascular benefit therefore did not arise from dramatic glucose improvement—the HbA1c reduction was only 0.46%. This suggests a glucose-independent component.
Why are the renal data important?
The 15% reduction in the renal endpoint was largely driven by less new macroalbuminuria (HR 0.77; p<0.0001). In a separate trial, AWARD-7, involving 577 patients with stage 3-4 chronic kidney disease, at week 52, eGFR was preserved with dulaglutide but declined with insulin glargine; severe hypoglycemia was 0-3% with dulaglutide and 7% with glargine. This is a clinically meaningful reason to prefer it in diabetic kidney disease.
Comparison with semaglutide—patients will ask
SUSTAIN 7 directly compared the drugs (1,201 patients, 40 weeks), and semaglutide was superior on both outcomes: HbA1c reduction: − 1.8% versus − 1.4% (p<0.0001); weight loss: −6.5 kg versus −3.0 kg (p<0.0001)—more than twice as much weight loss with semaglutide. Note: the trial preceded approval of dulaglutide 3.0 and 4.5 mg; as these strengths are unavailable in Türkiye, the comparison remains relevant here.
Dosing Schedule and Administration
| Step | Dose (1 dose weekly) | Escalation condition |
|---|---|---|
| Starting dose | 0.75 mg | Preferred for monotherapy and frail patients (e.g., older than 75) |
| Standard | 1.5 mg | Increase after at least 4 weeks . European labeling allows this as the initial dose in combination therapy. This is the practical maximum in Türkiye. |
| 3.0 mg (unavailable in Türkiye) | 3.0 mg | After at least 4 weeks on 1.5 mg |
| 4.5 mg (unavailable in Türkiye) | 4.5 mg— maximum dose | After at least 4 weeks on 3.0 mg |
How much additional benefit do higher doses provide?
In AWARD-11 (1,842 patients), at week 36, HbA1c reductions for 1.5 / 3.0 / 4.5 mg were respectively − 1.54% / − 1.64% / − 1.77%; weight loss was −3.0 / −3.7 / −4.6 kg . The HbA1c difference between 3.0 mg and 1.5 mg was not significant (p=0.096); only 4.5 mg was significantly superior (− 0.24%; p<0.001). Gastrointestinal discontinuation rose from 1.5% to 3.9%. Additional benefit is real but modest, with a tolerability cost.
Missed Dose—the 72-Hour Rule
- If the next scheduled dose is at least 3 days (72 hours) away , administer the missed dose as soon as possible.
- If less than 3 days remain, skip it and continue on the usual day.
- The injection day may change provided at least 3 days have elapsed since the last dose.
| Topic | Information |
|---|---|
| Pen | Single-use prefilled pen; fixed 0.5 mL volume. A box contains 4 pens (approximately 1 month). |
| Administration | Abdomen, thigh, or upper arm; any time of day, with or without food. Rotate sites for each injection. |
| Storage | Refrigerate at 2-8 °C; do not freeze, and protect from light. If necessary, for up to 14 days at no more than 30 °C, it may be kept outside the refrigerator. |
| Renal impairment | No dose adjustment even in severe impairment —an important advantage. However, European and Turkish labeling does not recommend use in end-stage renal disease (eGFR <15 mL/min/1.73 m²) (very limited experience). United States labeling advises caution in dialysis patients. Monitor for dehydration-related acute kidney injury during severe nausea, vomiting, or diarrhea. |
| Hepatic impairment | No dose adjustment; use cautiously because clinical experience is limited. |
| Children (age ≥10) | Start at 0.75 mg; increase to 1.5 mg after at least 4 weeks. The pediatric maximum is 1.5 mg —do not use 3.0 or 4.5 mg. |
Price, Authorization, and Reimbursement in Türkiye
| Presentation | Retail price (including VAT) | List date |
|---|---|---|
| Trulicity 0.75 mg / 0.5 mL— 4 pens | 13,238.20 TL | August 31, 2026 |
| Trulicity 1.5 mg / 0.5 mL— 4 pens | 13,238.20 TL | August 31, 2026 |
Prices increased during 2026
The same product cost, in the January 5 and March 2, 2026 lists, 11,518.76 TL; on March 23, 12,219.90 TL; and from March 31, 13,238.20 TL . Over eight months, this was an increase of approximately 15% . Equal pricing of the two strengths reflects Turkish pricing rules; increasing the dose does not change the cost.
Authorization and reimbursement
- Marketing authorization holder: Lilly İlaç Ticaret Ltd. Şti. · Imported (United States) · Active authorization
- ATC code: A10BJ05 · Prescription type: White prescription
- SGK: not reimbursed. The patient pays the full cost.
Why is it not reimbursed? What does the SUT say?
In SUT 4.2.38 (principles for medicine use in diabetes treatment) , the only active ingredient named in the GLP-1 group is exenatide. Conditions include inadequate glycemic control with maximum tolerated metformin and/or sulfonylurea doses, a pretreatment body mass index >35 kg/m², no acute pancreatitis history, and initiation and documentation by an endocrinologist. Dulaglutide, liraglutide, and semaglutide are not named in this provision and are therefore outside reimbursement coverage. This information was compiled from drug databases and reproductions of the SUT text; confirm the exact current status by barcode in the SUT Annex-4/A list.
Supply: not discontinued, but limited
No information indicates that Trulicity has been discontinued in any country. However, its manufacturer's supply page marks it as having "limited availability" —prescriptions can be fulfilled, but delays may occur. On June 26, 2024, the EMA also announced measures addressing GLP-1 supply shortages across the group. No Türkiye-specific shortage notification was identified.
Side Effects
| Side effect | Placebo | 0.75 mg | 1.5 mg |
|---|---|---|---|
| Nausea | 5.3% | 12.4% | 21.1% |
| Vomiting | 2.3% | 6.0% | 12.7% |
| Diarrhea | 6.7% | 8.9% | 12.6% |
| Abdominal pain | 4.9% | 6.5% | 9.4% |
| Decreased appetite | 1.6% | 4.9% | 8.6% |
| Indigestion | 2.3% | 4.1% | 5.8% |
| Fatigue | 2.6% | 4.2% | 5.6% |
At higher doses, unavailable in Türkiye, rates for 1.5 / 3.0 / 4.5 mg are: nausea 13.4% / 15.6% / 16.4%; diarrhea 7.0% / 11.4% / 10.7%; vomiting 5.6% / 8.3% / 9.3%. Gastrointestinal discontinuation at 52 weeks: 1.5% / 3.4% / 3.9%.
Boxed warning and contraindications
Boxed warning: In rats, dulaglutide increases the incidence of thyroid C-cell tumors (adenomas and carcinomas), depending on dose and treatment duration. Human relevance is unknown. Counsel patients about neck masses, difficulty swallowing, shortness of breath, and persistent hoarseness.
Contraindications: (1) Personal or family history of medullary thyroid cancer ; (2) MEN 2 syndrome; (3) serious hypersensitivity to dulaglutide or its components.
Other warnings
- Acute pancreatitis —stop treatment and obtain urgent assessment for severe, persistent abdominal pain.
- Hypoglycemia —not caused by treatment alone, but risk increases with insulin or sulfonylureas; reduce those medicines' doses.
- Acute kidney injury —may result from dehydration during severe nausea, vomiting, or diarrhea.
- Severe gastrointestinal side effects —the March 2026 label update added intestinal obstruction and severe constipation including fecal impaction to the postmarketing section.
- Diabetic retinopathy —rapid glucose improvement may cause temporary worsening in patients with retinopathy history; eye monitoring is required.
- Gallbladder disease —gallstone and inflammation risks increase.
Anesthesia and surgery: the rule changed in 2024
In November 2024, all GLP-1 medicines received a warning about aspiration of stomach contents into the lungs during general anesthesia or deep sedation . However, joint guidance from five societies dated October 29, 2024changed the previous recommendation to stop treatment before surgery:
- Most patients should continue treatment —routine discontinuation is not recommended
- For high-risk patients, before the procedure, a 24-hour liquid diet
- High risk: dose escalation (first 4-8 weeks), active gastrointestinal symptoms, high dose, or comorbidities delaying gastric emptying
- Always tell the anesthesia team you use this medicine.
The NAION warning does NOT apply to Trulicity
A common error in Turkish-language sources. The EMA's June 2025 recognition of NAION (optic nerve damage potentially causing sudden vision loss) as a very rare side effect applies to semaglutide-containing products only (Ozempic, Rybelsus, Wegovy). NAION appears in neither the United States nor European Trulicity labeling. It has not yet been accepted as a class effect.
Drug Interactions
- Insulin and sulfonylureas: Hypoglycemia risk increases. Reduce their doses and intensify glucose monitoring.
- Oral medicines: Delayed gastric emptying may affect absorption. Monitor narrow-therapeutic-range medicines such as levothyroxine and warfarin.
- Do not combine with other GLP-1 medicines —concurrent Ozempic, Wegovy, Saxenda, Byetta, or Mounjaro is not recommended.
- No interaction through cytochrome P450 is expected —dulaglutide is a peptide degraded through proteolysis.
An Oncology Perspective
Where do thyroid cancer concerns stand?
The boxed warning is based on rat data ; it is not a demonstrated human risk. In an international cohort spanning six countries (Thyroid, January 2025), GLP-1 users had no greater thyroid cancer risk than DPP-4 inhibitor users: HR 0.81 (95% CI 0.59-1.12).
Two limitations matter: follow-up was short, at 1.8-3 years, and cannot exclude long-term risk. In addition, agent-specific analysis was possible only for liraglutide; dulaglutide was not examined separately. No signal appeared over REWIND's 5.4-year follow-up either. The correct statement: no proven human risk, but the issue is not settled. The MTC and MEN 2 contraindications remain absolute.
There are no dulaglutide-specific cancer data. GLP-1 class meta-analyses published in 2025-2026 found no increase in overall or gastrointestinal cancer risk; observational reports of lower obesity-associated cancer risk largely rely on semaglutide and class-wide data.
Frequently Asked Questions
- Is Trulicity a weight-loss medicine?
- No. Trulicity is approved only for type 2 diabetes ; it has no obesity indication. Weight loss is an expected but modest side effect (mean 2.95 kg in REWIND). Using it for weight loss is off-label.
- Does SGK reimburse it?
- No. Monthly cost is 13,238.20 TL(August 2026), paid entirely by the patient. In the SUT diabetes provision, only exenatide has reimbursement conditions within the GLP-1 group.
- Can I find 3 mg or 4.5 mg in Türkiye?
- No. Only 0.75 mg and 1.5 mg are marketed in Türkiye. If a higher dose is needed, your physician may consider switching medicines.
- My kidney function is poor. Can I use it?
- Probably—Trulicity requires no adjustment even in severe renal impairment, an advantage over many diabetes medicines. However, it is not recommended below eGFR 15 or during dialysis. Your nephrologist and endocrinologist should decide together.
- I have nausea. What should I do?
- The most common side effect (21% at 1.5 mg), usually occurring early and decreasing. Small, frequent meals, slow eating, and avoiding fatty foods help. Your physician may keep you at 0.75 mg longer if necessary. Severe, persistent abdominal pain is different —it requires urgent assessment for pancreatitis.
- Should I switch to Ozempic?
- In SUSTAIN 7, semaglutide was superior for both glucose and weight. Trulicity, however, has two advantages: a cardiovascular indication including primary prevention and use in severe renal impairment. Decide individually with your physician; neither drug is reimbursed by SGK.
Summary
Trulicity is a once-weekly GLP-1 medicine for type 2 diabetes that lowers glucose and cardiovascular events. Its cardiovascular indication also covers patients without established heart disease who have only risk factors , a unique feature in its class. No dose adjustment in severe renal impairment is another important advantage.
Its weight effect is modest and was inferior to semaglutide in a direct comparison. Only 0.75 and 1.5 mg are available in Türkiye, SGK does not reimburse it, and monthly cost is 13,238.20 TL. It has not been discontinued, but supply may be limited worldwide.
- FDA. TRULICITY (dulaglutide) US Prescribing Information, rev. 03/2026. pi.lilly.com
- European Medicines Agency. Trulicity—Product Information (updated January 30, 2026). ema.europa.eu
- Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet 2019;394:121-130.
- Gerstein HC, et al. Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND trial. Lancet 2019;394:131-138.
- Frias JP, et al. Efficacy and safety of dulaglutide 3.0 mg and 4.5 mg versus dulaglutide 1.5 mg (AWARD-11). Diabetes Care 2021;44(3):765-773. diabetesjournals.org
- Pratley RE, et al. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7). Lancet Diabetes Endocrinol 2018;6:275-286.
- Tuttle KR, et al. Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7). Lancet Diabetes Endocrinol 2018;6:605-617.
- ASA et al. Multi-society clinical practice guidance for the perioperative management of patients on GLP-1 receptor agonists. October 29, 2024. asahq.org
- European Medicines Agency / PRAC. NAION is a very rare side effect of semaglutide-containing medicines. June 2025. ema.europa.eu
- GLP-1 reseptör agonistleri ve tiroit kanseri: uluslararası çok merkezli kohort çalışması. Thyroid 2025;35(1).
- SUT 4.2.38 — Diyabet tedavisinde ilaç kullanım ilkeleri.
Transparency note
Turkish prices were confirmed through 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. SGK reimbursement status was determined through two drug databases and reproductions of the SUT text; definitive status should be confirmed in the current SUT Annex-4/A list by barcode. AWARD-11's numerical week 52 results and pen-needle dimensions could not be verified from their sources and were omitted. No Türkiye-specific supply-shortage notification was found (absence of evidence). Prices change frequently, so check the pharmacy system before purchase.
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