Overview
Doravirine is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) intended to be administered in combination with other antiretroviral medicines. Doravirine is available by itself or as a combination product of doravirine (100 mg), lamivudine (300 mg), and tenofovir disoproxil fumarate (300 mg). Doravirine is formally indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, further expanding the possibility and choice of therapeutic treatments available for the management of HIV-1 infection.
Background
Doravirine is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) intended to be administered in combination with other antiretroviral medicines. Doravirine is available by itself or as a combination product of doravirine (100 mg), lamivudine (300 mg), and tenofovir disoproxil fumarate (300 mg). Doravirine is formally indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, further expanding the possibility and choice of therapeutic treatments available for the management of HIV-1 infection.
Indication
Doravirine is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history. It is also indicated to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.
Associated Conditions
- Human Immunodeficiency Virus Type 1 (HIV-1)
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/04/06 | Phase 4 | UNKNOWN | Clinique du Quartier Latin | ||
2020/01/18 | Phase 3 | Completed | |||
2019/09/20 | Phase 2 | Completed | Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | ||
2019/09/06 | Phase 3 | Completed | Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | ||
2019/03/28 | Phase 1 | Completed | Chelsea and Westminster NHS Foundation Trust | ||
2019/03/22 | Phase 1 | Completed | Walter K. Kraft | ||
2017/11/06 | Phase 1 | Completed | |||
2017/09/05 | Phase 2 | Completed | |||
2016/03/22 | Phase 1 | Completed | |||
2015/12/29 | Phase 1 | Completed |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||