Has semaglutide is approved in india for adolescence

Searching the Web

semaglutide approval India adolescents 2025 2026 CDSCO

Searching PubMed

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

This is a shared conversation. Sign in to Orris to start your own chat.