Overview
Rilpivirine is non-nucleoside reverse transcriptase inhibitor (NNRTI) which is used for the treatment of HIV-1 infections in treatment-naive patients. It is a diarylpyrimidine derivative. The internal conformational flexibility of rilpivirine and the plasticity of it interacting binding site gives it a very high potency and reduces the chance of resistance compared to other NNRTI's. Rilpivirine was developed by Tilbotec, Inc. and FDA approved on May 20, 2011. On November 21, 2017, Rilpivirine, in combination with dolutegravir, was approved as part of the first complete treatment regimen with only two drugs for the treatment of adults with HIV-1 named Juluca. Rilpivirine in combination with cabotegravir was granted FDA approval on 21 January 2021. While previously administered once-monthly only, this combination product was granted FDA approval for dosing every two months on February 01, 2022 and without the need for an oral lead-in period prior.
Indication
Rilpivirine, in combination with other agents, is indicated for the treatment of HIV-1 infections in antiretroviral treatment-naive patients with HIV-1 RNA ≤100,000 copies/mL and CD4+ cell count >200 cells/mm. The FDA combination therapy approval of rilpivirine and dolutegravir is indicated for adults and adolescents 12 years of age and older weighing at least 35 kg with HIV-1 infections whose virus is currently suppressed (< 50 copies/ml) on a stable regimen for at least six months, without a history of treatment failure and no known substitutions associated to resistance to any of the two components of the therapy. Rilpivirine in combination with cabotegravir is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents - ≥12 years old and weighing at least 35kg - to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
Associated Conditions
- Human Immunodeficiency Virus Type 1 (HIV-1)
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/24 | N/A | Active, not recruiting | University Hospital Virgen de las Nieves | ||
2024/05/08 | N/A | Recruiting | |||
2023/06/26 | Phase 3 | Active, not recruiting | |||
2023/06/09 | Phase 3 | Completed | |||
2023/06/09 | Phase 3 | Completed | |||
2022/05/03 | Phase 1 | Completed | |||
2021/09/16 | Not Applicable | Recruiting | |||
2020/09/09 | Phase 3 | Completed | |||
2020/05/01 | Phase 1 | Completed | |||
2019/08/22 | Phase 4 | UNKNOWN | A.O. Ospedale Papa Giovanni XXIII |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| ViiV Healthcare Company | 49702-231 | ORAL | 50 mg in 1 1 | 6/15/2023 | |
| ViiV Healthcare Company | 49702-228 | ORAL | 50 mg in 1 1 | 10/7/2022 | |
| ViiV Healthcare Company | 49702-242 | ORAL | 25 mg in 1 1 | 4/18/2024 | |
| ViiV Healthcare Company | 49702-242 | ORAL | 50 mg in 1 1 | 4/18/2024 | |
| ViiV Healthcare Company | 49702-226 | ORAL | 10 mg in 1 1 | 10/7/2022 | |
| Gilead Sciences, Inc. | 61958-1102 | ORAL | 25 mg in 1 1 | 11/30/2019 | |
| Mylan Laboratories Limited | 65015-353 | ORAL | 10 mg in 1 1 | 3/5/2021 | |
| ViiV Healthcare Company | 49702-255 | ORAL | 5 mg in 1 1 | 10/7/2022 | |
| Gilead Sciences, Inc. | 61958-2101 | ORAL | 25 mg in 1 1 | 9/17/2021 | |
| ViiV Healthcare Company | 49702-246 | ORAL | 50 mg in 1 1 | 4/18/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/31/2014 | ||
Authorised | 5/16/2018 | ||
Authorised | 5/16/2018 | ||
Authorised | 11/27/2011 | ||
Authorised | 6/21/2016 | ||
Authorised | 6/10/2022 | ||
Authorised | 11/28/2011 | ||
Authorised | 12/17/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| REKAMBYS PROLONGED-RELEASE SUSPENSION FOR INJECTION 300MG/ML | SIN16568P | INJECTION, SUSPENSION, EXTENDED RELEASE | 300mg/mL | 8/11/2022 | |
| EDURANT FILM-COATED TABLET 25 MG | SIN14363P | TABLET, FILM COATED | 25 mg | 6/11/2013 | |
| COMPLERA FILM-COATED TABLET 200MG/25MG/300MG | SIN14965P | TABLET, FILM COATED | 25 mg | 2/29/2016 | |
| ODEFSEY FILM-COATED TABLET 200MG/25MG/25MG | SIN16015P | TABLET, FILM COATED | 25mg | 9/25/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ODEFSEY 200 MG/25 MG/25 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1161112001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| EDURANT 25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 11736001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| REKAMBYS 900 MG SUSPENSION INYECTABLE DE LIBERACION PROLONGADA | 1201482002 | SUSPENSION INYECTABLE DE LIBERACION PROLONGADA | Diagnóstico Hospitalario | Commercialized | |
| EVIPLERA 200 mg/25 mg/245 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 11737001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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