XULTOPHY 100/3.6 (insulin degludec)
Xultophy 100/3.6 is a combination of insulin degludec, a long-acting insulin analog, and liraglutide, a GLP-1 receptor agonist. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The medication is not recommended for the treatment of diabetic ketoacidosis or for use in combination with other GLP-1 receptor agonists. Additionally, its use has not been studied in conjunction with prandial insulin.
How XULTOPHY 100/3.6 Works
This combination product utilizes two distinct mechanisms to regulate blood glucose levels. Insulin degludec lowers blood glucose by stimulating peripheral glucose uptake in skeletal muscle and fat while simultaneously inhibiting the production of glucose in the liver. Liraglutide functions as a GLP-1 receptor agonist that increases glucose-dependent insulin release and decreases the secretion of glucagon. Furthermore, liraglutide slows gastric emptying to assist in glycemic management.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2016-11-21
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
XULTOPHY 100/3.6 Approval History
What XULTOPHY 100/3.6 Treats
2 indicationsXULTOPHY 100/3.6 is approved for 2 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 Diabetes
- Diabetic Ketoacidosis
XULTOPHY 100/3.6 Boxed Warning
RISK OF THYROID C-CELL TUMORS • Liraglutide, one of the components of XULTOPHY 100/3.6, causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether XULTOPHY 100/3.6 causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Noncl...
WARNING: RISK OF THYROID C-CELL TUMORS • Liraglutide, one of the components of XULTOPHY 100/3.6, causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether XULTOPHY 100/3.6 causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13 )] . • XULTOPHY 100/3.6 is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of XULTOPHY 100/3.6 and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with XULTOPHY 100/3.6 [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • Liraglutide, one of the components of XULTOPHY 100/3.6, causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether XULTOPHY 100/3.6 causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. ( 5.1 , 13.1 ) • XULTOPHY 100/3.6 is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors. ( 4 , 5.1 )
XULTOPHY 100/3.6 Target & Pathway
ProTarget
A hormone released after eating that stimulates insulin secretion, suppresses glucagon, slows gastric emptying, and promotes satiety. GLP-1 receptor agonists mimic these effects, improving blood sugar control and promoting weight loss in diabetes and obesity.
XULTOPHY 100/3.6 Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in XULTOPHY 100/3.6's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications XULTOPHY 100/3.6 treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to XULTOPHY 100/3.6
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Clinical Trial Registry
114 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06685185 | NN1644-7794 2024-511808-17, U1111-1304-2544 | Ph 1 | completed | A Research Study of a New Medicine NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes |
| NCT06280703 | 18792 J4P-MC-IYAB, U1111-1301-8386 | Ph 1 | recruiting | A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM) |
| NCT04770532 ONWARDS 2 results posted | NN1436-4478 U1111-1247-4945, 2020-000454-10 | Ph 3 | completed | A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin |
| NCT04588259 results posted | NN1218-4357 U1111-1197-8289 | Ph 3 | completed | Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes |
| NCT04848480 ONWARDS 6 results posted | NN1436-4625 U1111-1251-7315, 2020-002374-27 | Ph 3 | completed | A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6) |
| NCT06767748 | GZR4-T2D-302 | Ph 3 | active not recruiting | A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin |
| NCT07018453 | SHR-3167-202 | Ph 2 | active not recruiting | A Study Comparing SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs |
| NCT04760626 ONWARDS 5 results posted | NN1436-4481 U1111-1247-5279, 2020-000476-38 | Ph 3 | completed | A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before |
| NCT05463744 QWINT-5 results posted | 18263 I8H-MC-BDCY, 2021-005892-38 | Ph 3 | completed | A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy |
| NCT05275400 results posted | 18237 I8H-MC-BDCU, 2021-002569-16 | Ph 3 | completed | A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin |
| NCT06288412 | NN1436-7615 U1111-1285-1665, 2023-505012-38 | Ph 1 | completed | A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Prolonged Fasting |
| NCT05362058 QWINT-2 results posted | 18262 I8H-MC-BDCX, 2021-005891-21 | Ph 3 | completed | A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time |
| NCT05243628 ABC results posted | MKC-TI-192 | Ph 4 | completed | Afrezza With Basal Combination (ABC): Afrezza® Combined With AID Pump or Insulin Degludec in Adults With Type 1 Diabetes |
| NCT04538352 TRANSITION-T2D results posted | 20-853 | Ph 4 | completed | Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D |
| NCT06202079 | GL-GZR-CH2007 | Ph 2 | completed | A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects with Type 2 Diabetes Mellitus |
| NCT04795531 ONWARDS 3 results posted | NN1436-4479 U1111-1247-5218, 2020-000472-37 | Ph 3 | completed | A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3) |
| NCT05218915 | BGLP-DKD | Ph 4 | completed | Basal Plus GLP1-ra on Glycemic Variability in CKD |
| NCT06556641 | GL-GZR-CH1013 | Ph 1 | completed | A Clinical Study of GZR33 and GZR101 in Healthy Subjects |
| NCT06553248 | GL-GZR-CH1016 | Ph 1 | completed | A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GZR4 in Subjects With Type 2 Diabetes |
| NCT05904743 | MKC-TI-193 | Ph 4 | completed | INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes |
| NCT06132126 | 18779 J4P-MC-IYAA | Ph 1 | completed | A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus |
| NCT04623086 GLIDING results posted | STUDY00008108 | Ph 4 | completed | Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose |
| NCT03862716 REMITiDegLira | REMITiDegLira | Ph 3 | completed | Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira |
| NCT04569994 | NN1845-4598 U1111-1244-4315, 2019-004658-27 | Ph 1 | completed | A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes |
| NCT03387787 | UDEM_GlucoTab | Ph 2, Ph 3 | completed | Evaluation of Glycaemic Control Using GlucoTab® With Insulin Degludec in Hospitalized Patients With Diabetes Mellitus Type 2 |
| NCT03952130 results posted | 16829 I8B-FH-ITSD | Ph 3 | completed | A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes |
| NCT03377699 EXPECT results posted | NN1250-4300 U1111-1191-3018, 2017-000048-17 | Ph 3 | completed | Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes |
| NCT04663282 | INS068-201 | Ph 2 | completed | A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics |
| NCT03172494 DUAL™ I China results posted | NN9068-4148 U1111-1154-6671, CTR20170004 | Ph 3 | completed | A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs) |
| NCT04450394 results posted | 17056 I8H-MC-BDCL, 2019-003339-53 | Ph 2 | completed | A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus |
| NCT03668808 SafrTravlT1D results posted | ISS-001227 U1111-1210-7350 | Ph 4 | completed | Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones. |
| NCT04450407 results posted | 17183 I8H-MC-BDCP, 2019-003589-41 | Ph 2 | completed | A Study of LY3209590 in Participants With Type 1 Diabetes |
| NCT04585776 results posted | 17601 I8B-MC-ITSZ | Ph 2 | completed | A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes |
| NCT02967224 Reach-Control | LPS13931 2015-001831-18, U1111-1170-8104 | Ph 4 | completed | A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulins in Insulin Naïve Patients Initiating Insulin |
| NCT02967211 REGAIN CONTROL | LPS14060 2015-001832-39, U1111-1170-8132 | Ph 4 | completed | A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulin in Patients Already Using Basal Insulin |
| NCT03952143 results posted | 16830 I8B-FH-ITSE | Ph 3 | completed | A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes |
| NCT03740919 PRONTO-Peds results posted | 16698 I8B-MC-ITSB, 2018-002371-18 | Ph 3 | completed | A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes |
| NCT03882970 SURPASS-3 results posted | 16997 I8F-MC-GPGH, 2018-003422-84 | Ph 3 | completed | A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes |
| NCT03078478 CONCLUDE results posted | NN1250-4252 U1111-1184-8175, 2016-002801-20 | Ph 3 | completed | A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs |
| NCT03268005 onset 9 results posted | NN1218-4113 U1111-1180-0636, 2016-000878-38 | Ph 3 | completed | Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes |
| NCT02964104 | NN1436-4314 2016-000436-18, U1111-1178-9795 | Ph 1 | completed | A Trial Investigating the Safety, Tolerability, Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Pharmacodynamics (the Effect of the Investigated Drug on the Body) of Insulin 287 in Subjects With Type 2 Diabetes |
| NCT02607306 DUAL™ I Japan results posted | NN9068-4183 U1111-1170-1332, JapicCTI-153089 | Ph 3 | completed | A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus. |
| NCT02911948 DUAL™ II Japan results posted | NN9068-4184 U1111-1178-3453, JapicCTI-163385 | Ph 3 | completed | A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs |
| NCT03736785 results posted | 17059 I8H-MC-BDCM | Ph 2 | completed | A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus |
| NCT02148861 | NN1436-4057 2013-001180-22, U1111-1140-5344 | Ph 1 | completed | A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes |
| NCT03687827 SWITCH PRO results posted | NN1250-4419 U1111-1203-0580, 2017-004047-20 | Ph 4 | completed | A Research Study to Compare the Effect of Insulin Degludec and Insulin Glargine on Blood Sugar Levels in People With Type 2 Diabetes - the SWITCH PRO Study |
| NCT04276428 | 16983 I8H-JE-BDCK | Ph 1 | completed | A Study of LY3209590 in Japanese Participants With Type 2 Diabetes Mellitus |
| NCT02680457 Diabetes results posted | CT-DG-140282-JLRN | Ph 4 | completed | Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus |
| NCT03214367 PRONTO-T1D results posted | 16313 I8B-MC-ITRM, 2015-005356-99 | Ph 3 | completed | A Study of LY900014 in Participants With Type 1 Diabetes |
| NCT03214380 PRONTO-T2D results posted | 16314 I8B-MC-ITRN, 2015-005357-12 | Ph 3 | completed | A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes |
Showing 50 of 114 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XULTOPHY 100/3.6 FDA Label Details
Indications & Usage
FDA Label (PDF)XULTOPHY 100/3.6 is indicated for the treatment of Type 2 Diabetes; Diabetic Ketoacidosis.
WARNING: RISK OF THYROID C-CELL TUMORS • Liraglutide, one of the components of XULTOPHY 100/3.6, causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether XULTOPHY 100/3.6 causes thyroid C-cel...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment