NDAORALTABLET
Approved
Sep 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
TYBOST (cobicistat) by Gilead Sciences is cytochrome p450 3a inhibitors [moa]. Approved for cytochrome p450 3a inhibitor [epc]. First approved in 2014.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TYBOST (cobicistat) is an oral small-molecule cytochrome P450 3A inhibitor approved in 2014 that acts as a pharmacokinetic booster. It is used as an adjunctive agent to enhance the bioavailability of protease inhibitors and other antiretrovirals in HIV treatment regimens. Cobicistat works by inhibiting CYP3A-mediated metabolism, allowing co-administered drugs to achieve higher and more stable plasma concentrations.
$0.266MPart D
Peak6.5 years to LOEMature product at peak sales with modest Part D spending; commercial team is likely optimizing existing market presence rather than driving rapid expansion.
Mechanism of Action
Cytochrome P450 3A Inhibitors
Pharmacologic Class:
Cytochrome P450 3A Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Participants.
Started Apr 2024
28 enrolled
Healthy Participants
A Trial of Cobicistat and Gemcitabine and Nab-Paclitaxel in Patients with Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma
Started Dec 2022
6 enrolled
CYP3A InhibitorAdvanced Stage or Metastatic Pancreatic Ductal AdenocarcinomaPancreatic Cancer+2 more
A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children
Started Aug 2022
15 enrolled
Human Immunodeficiency Virus (HIV)
A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Compared to the Co-administration of the Separate Available Formulations of Darunavir and Cobicistat Under Fed Conditions in Healthy Participants
Started Jun 2022
32 enrolled
Healthy
A Study to Compare the Drug Levels of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations and the Coadministration of the Individual Reference Products in Healthy Adults Under Fed Conditions
Started May 2022
42 enrolled
Healthy Participants
Worked on TYBOST at Gilead Sciences? Share your interview experience or compensation data (+7 days Pro)
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.