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Clinical Trials
229
3 active
Approvals
184
Total approvals
Agencies
4
Regulatory bodies
Founded
N/A
Active, not recruiting
2
0.9%
Completed
216
94.3%
Not yet recruiting
1
0.4%
Recruiting
3
1.3%
Terminated
Unknown
1.8%
Withdrawn
NMPA
National Medical Products Administration
15
FDA
Food and Drug Administration
127
PHILIPPINES
Philippines FDA
NPRA
National Pharmaceutical Regulatory Agency
39
- India's Subject Expert Committee recommended waiving local Phase III and bioequivalence trials for generic lenacapavir PrEP from Dr. Reddy's and Emcure Pharmaceuticals. - The waiver applies only to the HIV prevention (PrEP) indication, not to treatment of multidrug-resistant HIV-1, which requires additional pharmacokinetic and ethnicity data. - Marketing authorization would be conditional on mandatory post-marketing Phase IV efficacy studies, with protocols due to CDSCO within three months. - Lenacapavir, a first-in-class long-acting capsid inhibitor, showed zero infections in PURPOSE 1 and a 96% incidence reduction in PURPOSE 2.
