drugset

Drugs / Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC

Follow last change Jun 2023 re-read 9 days ago

Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC

also known as D/C/F/TAF

Investigated by: Janssen Research & Development, LLC

Trials 1

today NCT04661397 · Ph 1

202120222023202420252026

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 1	NCT04661397	Jan → Jul 2021	—	Janssen Research & Development, LLC	Completed	Met primary

News releases announcing trial results or a regulatory action · 5

Date	Issuer	Release
2019-04-11	Janssen Research & Development, LLC	Results Janssen Presents New Data from First Phase 3 Trial of a Single-Tablet Regimen in a Rapid Initiation Model of Care Demonstrating Safety and Efficacy with SYMTUZA® through 48 Weeks jnj.com ↗ A secondary endpoint of the study also showed that 97% of patients reported they were satisfied with their treatment.
2017-10-25	Janssen Research & Development, LLC	Results Investigational Darunavir-Based Single-Tablet Regimen Shows Positive Results in Previously Untreated HIV Patients in Pivotal Phase 3 AMBER Clinical Trial jnj.com ↗
2017-09-26	Janssen Research & Development, LLC	Regulatory European Commission Approves Symtuza® for the Treatment of HIV-1 In Adults and Adolescents in Europe jnj.com ↗ European Commission Approves Symtuza® for the Treatment of HIV-1 In Adults and Adolescents in Europe
2017-09-25	Janssen Research & Development, LLC	Regulatory Janssen Submits New Drug Application to U.S. Food and Drug Administration for the First Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1 jnj.com ↗ Janssen Submits New Drug Application to U.S. Food and Drug Administration for the First Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1
2016-09-12	Janssen Research & Development, LLC	Regulatory Janssen Submits Marketing Authorisation Application for Darunavir-Based Single Tablet Regimen for Treatment of HIV-1 to European Medicines Agency jnj.com ↗

All press releases naming this drug 5 releases

Date	Issuer	Release
2019-04-11	Janssen Research & Development, LLC	Janssen Presents New Data from First Phase 3 Trial of a Single-Tablet Regimen in a Rapid Initiation Model of Care Demonstrating Safety and Efficacy with SYMTUZA® through 48 Weeks jnj.com ↗
2017-10-25	Janssen Research & Development, LLC	Investigational Darunavir-Based Single-Tablet Regimen Shows Positive Results in Previously Untreated HIV Patients in Pivotal Phase 3 AMBER Clinical Trial jnj.com ↗
2017-09-26	Janssen Research & Development, LLC	European Commission Approves Symtuza® for the Treatment of HIV-1 In Adults and Adolescents in Europe jnj.com ↗
2017-09-25	Janssen Research & Development, LLC	Janssen Submits New Drug Application to U.S. Food and Drug Administration for the First Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1 jnj.com ↗
2016-09-12	Janssen Research & Development, LLC	Janssen Submits Marketing Authorisation Application for Darunavir-Based Single Tablet Regimen for Treatment of HIV-1 to European Medicines Agency jnj.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

Field	Value	Cited text
Known as	Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC	ClinicalTrials.gov intervention name — accepted as the source's own label NCT04661397 ↗
Known as	D/C/F/TAF	“Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is a fixed-dose combination (FDC) for the treatment of HIV-1 infection in adults and...” PMID 37335552 ↗ Jun 2023
Route	Oral	“Participants will receive a single dose of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC tablet orally as per assigned treatment sequence.” NCT04661397 ↗