Has semaglutide is approved in india for adolescence
Semaglutide (Ozempic/Wegovy) is approved in India for adults with type 2 diabetes and obesity. As of my training data, it was not approved in India specifically for adolescents - the approvals were for adults only. However, this may have changed, so let me check current information.
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semaglutide approval India adolescents 2025 2026 CDSCO
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semaglutide adolescents obesity approval
Yes - semaglutide (Wegovy) has been approved in India for adolescents. Here is a summary of what is confirmed:
Semaglutide Approval in India for Adolescents
CDSCO Approval - Key Details
The Central Drugs Standard Control Organisation (CDSCO) has approved semaglutide (Wegovy) for chronic weight management in adolescents aged 12 years and older with obesity and a body weight above 60 kg.
Criteria for use:
- Age: 12 years and older
- Diagnosis: Obesity
- Body weight: above 60 kg
Supporting Evidence - STEP TEENS Trial
The approval was supported by the STEP TEENS trial, which is the key pivotal study:
- Enrolled 201 adolescents with obesity
- Duration: 68 weeks
- Results:
- Semaglutide group achieved an average BMI reduction of 16.1%
- 77% of adolescents achieved at least a 5% reduction in BMI
- Placebo group showed a slight increase in BMI
Current Status in India (as of 2026)
| Drug | Indication | Status in India |
|---|---|---|
| Semaglutide injection (Wegovy 2.4 mg) | Chronic weight management - adults | Approved |
| Semaglutide injection (Wegovy 2.4 mg) | Chronic weight management - adolescents ≥12 yrs, >60 kg | Approved |
| Semaglutide tablets (Rybelsus) | Type 2 diabetes - adults | Approved since 2020 |
| Semaglutide tablets | Cardiovascular risk reduction in T2DM adults | Recommended for approval (Nov 2025 SEC meeting) |
Important Notes
- This is specifically Wegovy (semaglutide 2.4 mg weekly injection) - not the diabetes formulations (Ozempic or Rybelsus)
- The indication is chronic weight management (obesity), not type 2 diabetes, for the adolescent population
- Use should still be under medical supervision and is a prescription-only medication in India
- The STEP TEENS trial data and a systematic review on cost-effectiveness support the benefit-risk profile in this age group
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