Drugs / Dolutegravir/Rilpivirine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | JULUCA | HIV-associated cancer | 2018-07-17 | “JULUCA (dolutegravir/rilpivirine), a two-drug regimen, once-daily, single-pill for the treatment of HIV-1. A supplemental New Drug Application was submitted to the FDA” jnj.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05674656 | Jul 2023 → Jun 2026 overdue | HIV infectious disease | ViiV Healthcare | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2019-04-04 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES JULUCA (DOLUTEGRAVIR/RILPIVIRINE) MAINTAINS HIV VIRAL SUPPRESSION AT 148-WEEKS viivhealthcare.com ↗
With the SWORD data we now have three year data showing the excellent effectiveness and tolerability of Juluca, the first approved dolutegravir-based 2-drug regimen. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2019-04-04 | ViiV Healthcare | ViiV HEALTHCARE ANNOUNCES JULUCA (DOLUTEGRAVIR/RILPIVIRINE) MAINTAINS HIV VIRAL SUPPRESSION AT 148-WEEKS viivhealthcare.com ↗ |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dolutegravir/Rilpivirine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05674656 ↗ |