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Semaglutide B
Semaglutide B is a GLP-1 receptor agonist Small molecule drug developed by Novo Nordisk A/S. It is currently in Phase 3 development for Type 2 diabetes.
Semaglutide B is a glucagon-like peptide-1 (GLP-1) receptor agonist that mimics the action of the natural hormone GLP-1 to regulate blood sugar levels.
Semaglutide is a medication being studied for conditions such as non-alcoholic Steatohepatitis, type 2 diabetes, and obesity, as part of a combination formulation with NNC0194-0499. The exact mechanism of action of semaglutide is unknown.
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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). -
Big-pharma sponsor
+3.0pp
Novo Nordisk A/S is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Semaglutide B |
|---|---|
| Sponsor | Novo Nordisk A/S |
| Drug class | GLP-1 receptor agonist |
| Target | GLP-1R |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Semaglutide B works by binding to the GLP-1 receptor in the pancreas, stimulating insulin secretion and inhibiting glucagon release, which helps to lower blood glucose levels. This mechanism also leads to weight loss and improved cardiovascular risk factors.
Approved indications
- Type 2 diabetes
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
Key clinical trials
- People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
- Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease (PHASE2)
- A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease (PHASE2)
- A Study Comparing the Efficacy and Safety of HRS9531 Injection With Semaglutide Injection in Subjects With Obesity (PHASE3)
- A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight (PHASE3)
- A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes (PHASE2)
- A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes (PHASE3)
- A Non-interventional Study Investigating Semaglutide in Combination With Lifestyle-based Modifications for the Management of Obesity in Real-World Clinical Practice in Germany (WeGo Real Germany).
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:
- Semaglutide B CI brief — competitive landscape report
- Semaglutide B updates RSS · CI watch RSS
- Novo Nordisk A/S portfolio CI
Frequently asked questions about Semaglutide B
What is Semaglutide B?
How does Semaglutide B work?
What is Semaglutide B used for?
Who makes Semaglutide B?
What drug class is Semaglutide B in?
What development phase is Semaglutide B in?
What are the side effects of Semaglutide B?
What does Semaglutide B target?
Related
- Drug class: All GLP-1 receptor agonist drugs
- Target: All drugs targeting GLP-1R
- Manufacturer: Novo Nordisk A/S — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing