Tybost

(cobicistat)

ApprovedSmall molecule

Tybost is a small molecule that works as a Cytochrome P450 3a Inhibitor.[2] It is being used across 11 indications, with its most advanced program in Approved.[1]

Tybost is one of 294 small molecule programs targeting AIDS. It is currently in Approved.

Indications

Total Trials

Active Trials

293

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

AIDSApproved

HIV InfectionActive, not recruiting

PneumocystosisApproved

HIV-1 InfectionActive, not recruiting

MalariaApproved

Non-Small Cell Lung CancerApproved

COVID-19Approved

TuberculosisActive, not recruiting

BRAF V600E MutationRecruiting

TenofovirActive, not recruiting

AIDSApproved

Approved

HIV InfectionApproved

Active, not recruiting

PneumocystosisApproved

Approved

HIV-1 InfectionApproved

Active, not recruiting

MalariaApproved

Approved

Non-Small Cell Lung CancerApproved

Approved

COVID-19Approved

Approved

TuberculosisPreclinical

Active, not recruiting

BRAF V600E MutationPhase 1

Recruiting

TenofovirPhase 3

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Tybost

Gilead

Approved

35 2

Cabometyx

Bristol-Myers Squibb

Phase 3

9 3

DATROWAY

Daiichi Sankyo

Phase 3

5 4

Navmi

SSummit Therapeutics

Phase 3

7 5

Remeron

OOrganon and Co

Preclinical

1 6

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—7

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—8

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 10

PD-1 Inhibitors

BBioNTech US Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2/3Active, not recruiting

Tenofovir

NCT02016924

Q4 2027

PreclinicalRecruiting

Acute Myeloid Leukemia

NCT04065399

Q2 2028

Phase 1Recruiting

BRAF V600E Mutation

NCT06610682

Q4 2028

Phase 2Recruiting

AML, Adult

NCT06014489

Clinical

Trials by Indication[1]

Tenofovir6 trials

Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02475135·72 enrolled

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04661397·37 enrolled

A Bioequivalence Study of Darunavir, Emtricitabine, and Tenofovir Alafenamide, in the Presence of Cobicistat in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02578550·126 enrolled

Show 3 more trials

Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV

Active, not recruiting· Gilead logo

Gilead·Phase 2/3·NCT02016924·133 enrolled

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

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04236453·16 enrolled

Study to Evaluate the Relative Bioavailability of Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) as a Whole Tablet, as a Split Tablet, and as Crushed Tablet in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02984852·30 enrolled

Interaction5 trials

The Interaction of Two HIV Medications With Blood Clot Medications in Healthy Volunteers

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT01896622·40 enrolled

A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)

Completed· GSK logo

GSK·Phase 1·NCT02277600·32 enrolled

Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels

Terminated· Gilead logo

Gilead·Phase 1·NCT05458102·18 enrolled

Show 2 more trials

A Drug-drug Interaction Study Between Daclatasvir and Atazanavir/Ritonavir or Atazanavir/Cobicistat

Completed·RRadboud University Medical Center·Phase 1·NCT02565888·16 enrolled

KF2024#1-trial: Esketamine Interaction Study

Completed·HHelsinki University Central Hospital·Phase 1·NCT06726382·12 enrolled

Effectiveness2 trials

Pharmacokinetic Boosting of Olaparib to Improve Exposure, Tolerance and Cost-effectiveness

Recruiting·RRadboud University Medical Center·Phase 4·NCT05078671·160 enrolled

Improving Osimertinib Exposure and Cost-effectiveness Using Pharmacokinetic Boosting With Cobicistat

Recruiting·MMaastricht University Medical Center·Phase 4·NCT05748093·60 enrolled

Fed1 trial

A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04718805·22 enrolled

Adult1 trial

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

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05236738·42 enrolled

18 more indications

Tics1 trial

A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Volunteers.

Completed·FFore Biotherapeutics·Phase 1·NCT06385119·28 enrolled

Drug1 trial

Electrophysiological Effects of Potential QT Prolonging Drugs

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT05716854·44 enrolled

HIV-Infected Individuals1 trial

Effect of Cobicistat Versus Ritonavir Boosting on the Brain Permeation of Darunavir in HIV-infected Individuals

Terminated·UUniversity Hospital, Basel, Switzerland·Phase 4·NCT02503462·7 enrolled

Tuberculosis1 trial

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT04518228·205 enrolled

Plasmodium Falciparum1 trial

First-in-Human Study of an Oral Plasmodium Falciparum Plasma Membrane Protein Inhibitor

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT02661373·44 enrolled

Prostate Cancer1 trial

ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer

Completed·CConstellation Pharmaceuticals·Phase 1/2·NCT03480646·175 enrolled

ESS1 trial

A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01619527·133 enrolled

MPA1 trial

Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01837719·64 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

A Trial of Cobicistat and Gemcitabine and Nab-Paclitaxel in Patients with Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma

Terminated·GGerman Cancer Research Center·Phase 1·NCT05494866·6 enrolled

Completed· GSK logo

GSK·Phase 2·NCT03045861·33 enrolled

Osimertinib1 trial

Pharmacokinetic Boosting of Osimertinib

Completed·AAcademisch Ziekenhuis Maastricht·Phase 1·NCT03858491·11 enrolled

HIV-1 infection1 trial

An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments

Recruiting· Gilead logo

Gilead·Approved·NCT06337032·350 enrolled

Acute Myeloid Leukemia1 trial

A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

Recruiting·SSyndax Pharmaceuticals·Preclinical·NCT04065399·447 enrolled

AML, Adult1 trial

A Single Arm Phase II Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine (sc) in Adult Patients With Newly Diagnosed Acute Myeloid Leukaemia (AML) Who Are Not Considered Candidates for Intensive Treatment Regimens

Recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 2·NCT06014489·142 enrolled

BRAF V600E Mutation1 trial

A Trial to Evaluate Deoxyribonucleic) in BRAF (V-raf Murine Sarcoma Viral Oncogene Homolog B1)-Altered Glioma During Treatment With Plixorafenib Alone or With Retifanlimab

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT06610682·24 enrolled

Unspecified3 trials

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

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04263350·34 enrolled

Taste Properties of Atazanavir and Cobicistat

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02307656·6 enrolled

A Study of PBI-200 With Ritonavir or Cobicistat in Healthy Volunteers

Completed·PPyramid Biosciences·Phase 1·NCT05692570·21 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 20, 2025

TYBOST

NDA NDA203094

Sources

References

[1]
ClinicalTrials.gov — 35 trial records for cobicistat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — cobicistat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for cobicistat. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA203094). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Tybost. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Gilead company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cytochrome P450 3a Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Gilead

Patent Landscape[5]

Patent Cliff

Sep 3, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8148374Sep 3, 2029

8148374*PEDMar 3, 2030

10039718*PEDApr 6, 2033

Tybost

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2027

Q2 2028

Q4 2028

Trials by Indication[1]

Tenofovir6 trials

Interaction5 trials

Effectiveness2 trials

Fed1 trial

Adult1 trial

Tics1 trial

Drug1 trial

HIV-Infected Individuals1 trial

Tuberculosis1 trial

Plasmodium Falciparum1 trial

Prostate Cancer1 trial

ESS1 trial

MPA1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Clinical Trial1 trial

Anticoagulant1 trial

Immunodeficiency1 trial

Osimertinib1 trial

HIV-1 infection1 trial

Acute Myeloid Leukemia1 trial

AML, Adult1 trial

BRAF V600E Mutation1 trial

Unspecified3 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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