Drugs / Symtuza
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | SYMTUZA | — | 2018-07-17 | fda.gov ↗ |
| Approved | EU (EMA) | Symtuza | — | 2017-09-21 | europa.eu ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03696160 | Mar 2019 → Jun 2024 | HIV infectious disease | NEAT ID Foundation | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT05463783 | Mar 2023 → Mar 2025 | HIV infectious disease, obesity disorder | East Carolina University | Unknown | No outcome recorded |
| Phase 4 | NCT04240210 | Sep 2019 → Dec 2021 | HIV infectious disease | Midland Research Group, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03685500 | Dec 2018 → Jun 2020 | HIV infectious disease | Fundacion SEIMC-GESIDA | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| 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 |
All press releases naming this drug 3 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 ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Symtuza | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03696160 ↗ |
| Known as | D/C/F/TAF | “Symtuza is a combination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide (D/C/F/TAF)” NCT03696160 ↗ |
| Known as | TAF/FTC/DRV/c | “Symtuza® (TAF/FTC/DRV/c)” NCT03685500 ↗ |
| Route | Oral | “taken orally once daily for up to 48 weeks with the addition of food” NCT03696160 ↗ |