Data updated: May 26, 2026
PREZCOBIX PED (cobicistat)
Trial Activity: Declining 5 active trials
Approved 2026-02-27
Development Insights
Bristol-Myers Squibb conducting 4 trials (15%)
25 indications explored (Broad Platform)
→ healthy (5 trials)
→ healthy participants (4 trials)
→ hiv infections (2 trials)
1
Indication
--
Phase 3 Trials
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2026-02-27
- Routes
- ORAL
- Dosage Forms
- TABLET, FOR SUSPENSION
PREZCOBIX PED Approval History
Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
What PREZCOBIX PED Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
Other
(1 approval)- • Approved indication (Feb 2026) NewLetter
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Clinical Trial Registry
26 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02016924 | GS-US-216-0128 2013-001402-28, IS000883 | Ph 2, Ph 3 | active not recruiting | Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV |
| NCT06385119 results posted | F8394-101 | Ph 1 | completed | A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Participants. |
| NCT04065399 AUGMENT-101 | SNDX-5613-0700 2020-004104-34 | Ph 1, Ph 2 | recruiting | A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation |
| NCT03480646 results posted | 1205-201 | Ph 1, Ph 2 | completed | ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer |
| NCT04718805 | CR108955 TMC114IFD1004, 2020-003397-43 | Ph 1 | completed | A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions |
| NCT04661397 | CR108922 2020-003396-18, TMC114FD2HTX1007 | Ph 1 | completed | A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents |
| NCT02578550 | CR107887 TMC114FD2HTX1001, 2015-001264-18 | Ph 1 | completed | A Bioequivalence Study of Darunavir, Emtricitabine, and Tenofovir Alafenamide, in the Presence of Cobicistat in Healthy Participants |
| NCT05458102 results posted | GS-US-382-1587 | Ph 1 | terminated | Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels |
| NCT05748093 OSIBOOST 2 | OSIBOOST 2 2023-505700-35-00 | Ph 4 | recruiting | Improving Osimertinib Exposure and Cost-effectiveness Using Pharmacokinetic Boosting With Cobicistat |
| NCT05078671 PROACTIVE | PROACTIVE | Ph 4 | recruiting | Pharmacokinetic Boosting of Olaparib to Improve Exposure, Tolerance and Cost-effectiveness |
| NCT06014489 HO171 | HO171 | Ph 2 | recruiting | A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML |
| NCT03864406 results posted | 190063 19-CC-0063 | Ph 1 | completed | Impact of Steady State Cobicistat and Darunavir/Cobicistat on the Pharmacokinetics and Pharmacodynamics of Oral Anticoagulants (Rivaroxaban, Apixaban) in Health Volunteers |
| NCT05716854 | SCR-014 | Ph 1 | completed | Electrophysiological Effects of Potential QT Prolonging Drugs |
| NCT05236738 | AI424-578 | Ph 1 | completed | 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 |
| NCT02307656 | AI424-517 | Ph 1 | completed | Taste Properties of Atazanavir and Cobicistat |
| NCT04263350 | AI424-567 | Ph 1 | completed | A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time |
| NCT02565888 DATE-4 | UMCN-AKF 14.12 | Ph 1 | completed | A Drug-drug Interaction Study Between Daclatasvir and Atazanavir/Ritonavir or Atazanavir/Cobicistat |
| NCT04236453 | CR108649 2019-002245-37, TMC114FD2HTX1005 | Ph 1 | terminated | A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents |
| NCT03045861 results posted | 200911 | Ph 2 | completed | Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults |
| NCT02661373 | BUZZOFF | Ph 1 | completed | First-in-Human Study of an Oral Plasmodium Falciparum Plasma Membrane Protein Inhibitor |
| NCT02277600 | 206285 AI438-044 | Ph 1 | completed | A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI) |
| NCT02475135 | CR107430 2015-001213-27, TMC114FD2HTX1002 | Ph 1 | completed | Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination |
| NCT01896622 | 130160 13-CC-0160 | Ph 1 | completed | The Interaction of Two HIV Medications With Blood Clot Medications in Healthy Volunteers |
| NCT02503462 | DRVCOBI | Ph 4 | terminated | Effect of Cobicistat Versus Ritonavir Boosting on the Brain Permeation of Darunavir in HIV-infected Individuals |
| NCT01837719 Atazanavir results posted | AI424-511 | Ph 1 | completed | Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat |
| NCT01619527 | CR100699 TMC114IFD1003, 2012-000273-23 | Ph 1 | completed | A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PREZCOBIX PED FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment