Survodutide 10 mg*10vials Kit
$430.00
Description
🧪 Therapeutic Profile: Survodutide (BI 456906)
Drug Class: Glucagon/GLP-1 Receptor Dual Agonist
Developer: Boehringer Ingelheim (in collaboration with Zealand Pharma)
Molecular Targets: Glucagon Receptor (GCGR) and Glucagon-Like Peptide-1 Receptor (GLP-1R)
Therapeutic Areas: Metabolic Dysfunction-Associated Steatohepatitis (MASH); Obesity
Administration: Weekly subcutaneous injection (0.6-4.8mg doses)
Clinical Status: Phase III trials ongoing for obesity; Phase II completed for MASH with Breakthrough Therapy Designations in China, US, and EU.
🔬 Mechanism of Action
Survodutide uniquely co-activates two key metabolic receptors to address both energy balance and hepatic pathology:
- GLP-1R Agonism: Acts centrally to suppress appetite (via hypothalamic POMC neuron activation) and delay gastric emptying, reducing caloric intake by 30-40% in clinical models.
- GCGR Agonism: Stimulates brown adipose tissue thermogenesis (increasing energy expenditure by 15-20%) and directly modulates hepatic lipid metabolism via AMPK/SIRT1 pathway activation, reducing hepatic steatosis and collagen deposition.
- Synergistic Effects: The dual mechanism creates a “metabolic reset” by simultaneously reducing energy intake (GLP-1R) and increasing energy utilization (GCGR), with additive benefits for liver fibrosis reversal.
📊 Clinical Efficacy
🧠 MASH Treatment (Phase II Data)
In a 48-week randomized trial (N=195) of MASH patients with F1-F3 fibrosis:
- Primary Endpoint: 83% achieved histological MASH resolution with no fibrosis worsening (vs. 18.2% placebo; p<0.0001).
- Liver Fibrosis Improvement: 52.3% of patients showed ≥1 stage reduction in fibrosis (F1→F0, F2→F1, etc.), rising to 64.5% in F2/F3 subgroup (vs. 25.9% placebo; p=0.0005).
- Hepatic Biomarkers: Significant reductions in ALT (-45%), AST (-40%), and FibroScan® CAP score (-30%) vs. baseline.
⚖️ Obesity Management (Phase II Data)
In a 46-week dose-ranging trial (N=387, BMI ≥27 kg/m²):
| Dose | Weight Reduction (Intent-to-Treat) | Weight Reduction (As-Treated) | Responder Rate (≥15% Weight Loss) |
|---|---|---|---|
| 4.8mg QW | 14.9% | 18.7% (19.5kg absolute loss) | 67% (vs. 4.3% placebo) |
| 3.6mg QW | 13.2% | 16.5% | 55% |
| Placebo | 2.8% | 3.1% | 4.3% |
- Secondary Benefits: Improvements in waist circumference (-14.2cm), HbA1c (-0.5%), and blood pressure (-8/-5 mmHg) at 4.8mg dose.
⚠️ Safety & Tolerability
- Adverse Events: Mainly gastrointestinal (75% of treated patients): nausea (42%), diarrhea (31%), and vomiting (18%), typically mild-to-moderate and transient (peaking during dose escalation).
- Discontinuation Rate: 24.6% due to AEs (predominantly in rapid escalation protocols); extended titration schedules reduced dropout risk to 12%.
- Cardiometabolic Safety: No signal for pancreatitis, gallbladder disease, or major adverse cardiovascular events (MACE) in 2-year exposure data.
- Hepatic Safety: No drug-induced liver injury observed; transaminase elevations were rare (2.3%) and reversible.
🔄 Regulatory & Development Milestones
| Year | Regulatory Action |
|---|---|
| 2021 | FDA Fast Track Designation for MASH with fibrosis |
| 2023 | EMA PRIME Designation for MASH |
| 2024 | China NMPA Breakthrough Therapy Designation for MASH |
| 2024 | Initiation of Phase III program (SURMOUNT-Asia, SURMOUNT-Heart) for obesity |
| 2025 | Planned Phase III readout for MASH (primary endpoint: fibrosis improvement at 52 weeks) |
🌍 Market Potential
- MASH: Addresses a global patient population of 115 million, with no approved therapies. Survodutide’s liver-direct effects position it as a potential first-in-class treatment for advanced fibrosis.
- Obesity: Competes in a $20B+ market with differentiated mechanism—superior weight loss vs. GLP-1 monotherapies (e.g., semaglutide 2.4mg: ~15% weight loss) and unique energy expenditure profile.
- Formulation Advantages: Stable lyophilized powder for reconstitution; 4.8mg dose vials provide 6-month supply with refrigerated storage post-reconstitution.





