Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
UB-421 Q2W · 1 trial · 1 indication
the incidence of Grade 3 drug-related treatment-emergent adverse events
| Arm | Type | Description |
|---|---|---|
| Standard ART | NO_INTERVENTION | Subjects will receive standard ART for 48 weeks |
| UB-421(25mg/kg) Q2W add-on treatment | EXPERIMENTAL | UB-421(25 mg/kg) Q2W plus standard ART for 48 weeks |
| UB-421(25mg/kg) Q4W add-on treatment | EXPERIMENTAL | UB-421(25 mg/kg) Q4W plus standard ART for 48 weeks |
| Name | Type | Description |
|---|---|---|
| UB-421(25 mg/kg) Q2W | BIOLOGICAL | Monoclonal antibody by IV infusion plus standard ART |
| UB-421(25 mg/kg) Q4W | BIOLOGICAL | Monoclonal antibody by IV infusion plus standard ART |
Inclusion Criteria: 1. HIV-1 sero-positive 2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg. 3. HIV-1 plasma RNA level below 50 RNA copies/mL . Exclusion Criteria: 1. Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may conf...
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UB-421 Q2W is a monoclonal antibody being developed for the treatment of HIV-1 infection. It is currently in Phase 2 clinical development and is being studied for its potential to achieve a functional cure in patients with HIV-1 who have stabilized on antiretroviral therapy.
UB-421 Q2W is being developed by United Therapeutics Corporation, a publicly traded company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with HIV-1 infection.
UB-421 Q2W is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to evaluate its potential in treating HIV-1 infection.
UB-421 Q2W has been studied in one completed Phase 2 clinical trial with the identifier NCT03743376. This trial, titled 'The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients,' enrolled 31 participants with HIV-1 infection in Taiwan and evaluated the drug's potential for achieving a functional cure.
UB-421 Q2W is a specific dosing regimen of the monoclonal antibody UB-421, administered every two weeks. The drug is being developed by United Therapeutics Corporation for the treatment of HIV-1 infection and is currently in Phase 2 clinical development.