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.
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/24 | Phase 2 | Recruiting | |||
2024/09/19 | Phase 4 | Recruiting | |||
2024/08/19 | Phase 3 | Recruiting | |||
2023/03/09 | N/A | Completed | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba | ||
2022/12/13 | Phase 4 | Recruiting | |||
2022/11/29 | Phase 4 | Recruiting | |||
2022/08/18 | Phase 4 | Active, not recruiting | Fundacion Clinic per a la Recerca Biomédica | ||
2022/04/11 | N/A | UNKNOWN | |||
2022/01/21 | N/A | UNKNOWN | University of Roma La Sapienza | ||
2021/09/22 | Phase 2 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Merck Sharp & Dohme LLC | 0006-3069 | ORAL | 100 mg in 1 1 | 11/14/2023 | |
| Merck Sharp & Dohme LLC | 0006-5007 | ORAL | 100 mg in 1 1 | 6/12/2025 | |
| A-S Medication Solutions | 50090-6268 | ORAL | 100 mg in 1 1 | 11/14/2023 | |
| A-S Medication Solutions | 50090-6237 | ORAL | 100 mg in 1 1 | 6/13/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/22/2018 | ||
Authorised | 11/22/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PIFELTRO FILM-COATED TABLET 100MG | SIN15869P | TABLET, FILM COATED | 100.0mg | 12/12/2019 | |
| DELSTRIGO FILM COATED TABLET 100MG/300MG/300MG | SIN15909P | TABLET, FILM COATED | 100mg | 3/13/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Doravirine Tablets | 国药准字HJ20200050 | 化学药品 | 片剂 | 11/24/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PIFELTRO doravirine 100 mg film-coated tablet bottle | 297701 | Medicine | A | 2/4/2019 |
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