Overview
Lopinavir is an antiretroviral protease inhibitor used in combination with other antiretrovirals in the treatment of HIV-1 infection. Lopinavir is marketed and administered exclusively in combination with ritonavir - this combination, first marketed by Abbott under the brand name Kaletra in 2000, is necessary due to lopinavir's poor oral bioavailability and extensive biotransformation. Ritonavir is a potent inhibitor of the enzymes responsible for lopinavir metabolism, and its co-administration "boosts" lopinavir exposure and improves antiviral activity. Like many other protease inhibitors (e.g. saquinavir, nelfinavir), lopinavir is a peptidomimetic molecule - it contains a hydroxyethylene scaffold that mimics the peptide linkage typically targeted by the HIV-1 protease enzyme but which itself cannot be cleaved, thus preventing the activity of the HIV-1 protease. Lopinavir was previously under investigation in combination with ritonavir for the treatment of COVID-19 caused by SARS-CoV-2.
Indication
用于高效抗逆转录病毒疗法（HAART）的组成药物。
Associated Conditions
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/29 | Phase 4 | Recruiting | |||
2023/06/29 | Phase 1 | Recruiting | |||
2022/04/19 | Phase 1 | Recruiting | |||
2021/08/27 | Not Applicable | Completed | |||
2020/07/07 | Phase 2 | Withdrawn | ProgenaBiome | ||
2020/05/06 | Not Applicable | Completed | Baqiyatallah Medical Sciences University | ||
2020/04/28 | Phase 3 | Withdrawn | |||
2020/04/21 | Phase 2 | Terminated | |||
2020/04/17 | Phase 4 | UNKNOWN | |||
2020/04/17 | Phase 4 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AbbVie Inc. | 0074-6799 | ORAL | 200 mg in 1 1 | 7/10/2023 | |
| Lannett Company, Inc. | 0527-1947 | ORAL | 80 mg in 1 mL | 11/18/2020 | |
| AbbVie Inc. | 0074-3956 | ORAL | 80 mg in 1 mL | 7/10/2023 | |
| Mylan Laboratories Limited | 65015-299 | ORAL | 40 mg in 50 mg | 2/6/2019 | |
| NuCare Pharmaceuticals,Inc. | 68071-2949 | ORAL | 200 mg in 1 1 | 3/6/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-603 | ORAL | 100 mg in 1 1 | 6/3/2021 | |
| Laurus Labs Limited | 42385-933 | ORAL | 100 mg in 1 1 | 3/23/2022 | |
| AbbVie Inc. | 0074-0522 | ORAL | 100 mg in 1 1 | 7/10/2023 | |
| Laurus Labs Limited | 42385-934 | ORAL | 200 mg in 1 1 | 3/23/2022 | |
| Camber Pharmaceuticals, Inc. | 31722-556 | ORAL | 200 mg in 1 1 | 6/3/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/14/2016 | ||
Authorised | 3/19/2001 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| KALETRA ORAL SOLUTION | SIN11492P | SYRUP | 80 mg | 4/18/2001 | |
| Kaletra Tablet 200mg/50mg | SIN13250P | TABLET, FILM COATED | 200.0mg | 4/12/2007 |
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 |
|---|---|---|---|---|---|
| LOPINAVIR AND RITONAVIR TABLETS USP 100MG/25MG | N/A | N/A | N/A | 5/20/2020 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| KALETRA TABLETS lopinavir 200mg and ritonavir 50mg tablets bottle | 121055 | Medicine | A | 5/24/2006 | |
| KALETRA oral solution bottle | 78627 | Medicine | A | 8/7/2001 |
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