TENUATE
LOE ApproachingNDAORALTABLET
Approved
Mar 1975
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
2/8 — Basic
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TENUATE is an oral small-molecule tablet approved in 1975 as a legacy NDA product by Sanofi. The specific indication and mechanism of action are not publicly detailed in available data, limiting characterization of its therapeutic role.
LOE Approaching
Product faces near-term loss of exclusivity with moderate competitive pressure (30/100), suggesting a contracting commercial team and transition-focused roles.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Safety, and Efficacy Study of ShigETEC, a Live, Attenuated, Oral Combination Vaccine to Prevent Shigella and ETEC Disease Delivered to Healthy Adults Ages 18 to 50 Years Old
Started Jun 2025
72 enrolled
Shigella
PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)
Started Jan 2025
400 enrolled
Rotavirus Gastroenteritis
Synbiotic to Attenuate Resorption of the Skeleton
Started Aug 2024
220 enrolled
OsteoporosisInflammationAging
Study of the Infectivity, Safety and Immunogenicity of Two Recombinant, Live-Attenuated, B/HPIV3 Vectored Vaccines Expressing the Fusion Glycoprotein of HMPV Delivered by Nasal Spray to HPIV3-Seropositive Children 24 to <60 Months of Age
Started Jul 2024
24 enrolled
Human MetapneumovirusHuman Parainfluenza Virus Type 3
Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Started May 2024
2,226 enrolled
RSV Immunization
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.