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Single insulin injections
Single insulin injections is a Small molecule drug developed by DreaMed Diabetes. It is currently in Phase 2 development.
Single insulin injections are used to treat conditions such as Diabetic Nephropathy, Diabetic Retinopathy, Keloid, Diabetes, and Type 2 Diabetes. They work by acting as an insulin receptor agonist, binding to the insulin receptor protein to stimulate insulin activity.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Single insulin injections |
|---|---|
| Sponsor | DreaMed Diabetes |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Exenatide for Smoking Cessation and Prevention of Weight Gain (PHASE2)
- Efficacy and Safety of Combined Nanofat Injection With Either Platelet Rich Fibrin or Microneedling Versus Nanofat Injection Alone in the Treatment of Facial Atrophic Post Acne Scars (NA)
- Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers (PHASE2, PHASE3)
- Oral Anti Diabetic Agents in the Hospital (PHASE4)
- Pediatric Insulin Plan Calculator for T1DM Management (NA)
- A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes (PHASE3)
- Bionic Pancreas in CFRD (PHASE3)
- Empagliflozin and Anakinra for the Treatment of Postprandial Hypoglycemia in Patients With Prediabetes (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:
- Single insulin injections CI brief — competitive landscape report
- Single insulin injections updates RSS · CI watch RSS
- DreaMed Diabetes portfolio CI
Frequently asked questions about Single insulin injections
What is Single insulin injections?
Who makes Single insulin injections?
What development phase is Single insulin injections in?
Related
- Manufacturer: DreaMed Diabetes — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing