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Insulin Degludec Injection
Insulin Degludec Injection is a Long-acting basal insulin analog Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd.. It is currently in Phase 3 development for Type 1 diabetes mellitus, Type 2 diabetes mellitus.
Insulin degludec is a long-acting basal insulin that binds to the insulin receptor to promote glucose uptake and utilization in peripheral tissues while suppressing hepatic glucose production.
Insulin degludec is a long-acting basal insulin that binds to the insulin receptor to promote glucose uptake and utilization in peripheral tissues while suppressing hepatic glucose production. Used for Type 1 diabetes mellitus, Type 2 diabetes mellitus.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Insulin Degludec Injection |
|---|---|
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Drug class | Long-acting basal insulin analog |
| Target | Insulin receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Insulin degludec is a ultra-long-acting insulin analog engineered with a 16-carbon fatty acid chain that enables multi-hexamer formation and subcutaneous depot formation, resulting in an exceptionally long half-life of approximately 25 hours and a duration of action exceeding 42 hours. It binds to the human insulin receptor with similar affinity to human insulin, activating downstream signaling pathways that increase glucose uptake in muscle and adipose tissue and inhibit gluconeogenesis in the liver. This extended duration allows for once-daily dosing with stable, predictable glucose-lowering effects.
Approved indications
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
Common side effects
- Hypoglycemia
- Injection site reactions
- Weight gain
- Headache
Key clinical trials
- Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes (PHASE4)
- Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes (PHASE2)
- Single-ascending Dose Study of HEC-151 Injection (PHASE1)
- 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 (PHASE3)
- 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) (PHASE3)
- Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes (PHASE3)
- Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T2DM (NA)
- A Study Comparing SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Insulin Degludec Injection CI brief — competitive landscape report
- Insulin Degludec Injection updates RSS · CI watch RSS
- Jiangsu HengRui Medicine Co., Ltd. portfolio CI
Frequently asked questions about Insulin Degludec Injection
What is Insulin Degludec Injection?
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Who makes Insulin Degludec Injection?
What drug class is Insulin Degludec Injection in?
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What are the side effects of Insulin Degludec Injection?
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Related
- Drug class: All Long-acting basal insulin analog drugs
- Target: All drugs targeting Insulin receptor
- Manufacturer: Jiangsu HengRui Medicine Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 1 diabetes mellitus
- Indication: Drugs for Type 2 diabetes mellitus
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing