Albuvirtide

Associated long-acting platforms

Aqueous drug particle suspension

Administration route

Intravenous

Therapeutic area(s)

Use case(s)

Use of drug

Dosage

Drug information

Delivery device(s)

No delivery device

Scale-up prospects

Frontier signed a global licensing agreement with GSK

Tentative equipment list for manufacturing

Not provided

Manufacturing

Formulation Preparation i) API dissolved with excipients in formulation buffer. ii) Sterile Filtration iii) Passage through a 0.22 μm sterilising-grade filter. iv) Aseptic Filling v) Sterile solution filled into depyrogenated glass vials. vi) Lyophilisation (Freeze-Drying) - Product freeze-dried to obtain stable powder. vi) Vials stoppered under controlled conditions and sealed. vii) Secondary packaging and sterilisation. viii) Finished Product Testing

Specific analytical instrument required for characterization of formulation

Not provided

FB-ABWT-402

Identifier

NCT05206019

Link

https://clinicaltrials.gov/study/NCT05206019

Phase

Phase I

Status

Completed

Sponsor

Frontier Biotechnologies Inc.

More details

This is a single-center,randomized,open, single-dose, parallel-design study, which will be only enrolled Chinese healthy volunteers.

Purpose

Study to Evaluate Pharmacokinetic and Safety of Albuvirtide Between Intravenous Drip and Intravenous Injection

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-02-16

Anticipated Date of Last Follow-up
2023-01-05

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2022-04-17

Actual Completion Date
2022-05-02

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: 1. Age of 18-55, healthy volunteers (including the threshold, based on time of signing informed consent form). 2. BMI of 19 to 26 kg/m2 (including the threshold), with male ≥ 50 kg and female ≥ 45 kg. 3. Subjects and their partners agreed never to have children from 2 weeks prior to screening until 6 months after administration and volunteered to use effective contraception, regardless of sperm or oocyte donation plans. Exclusion Criteria: 1. Allergic to investigational drug or allergic constitution . 2. With difficulty in intravenous administration/blood collection or a history of dizziness from needles and blood. 3. Have substance abuse in the past 5 years or used drugs in the past 3 months prior to screening, or drug tested positive. 4. Smoked an average of \>5 ci

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

30

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

ABT-3BNC117_202

Identifier

NCT04819347

Link

https://clinicaltrials.gov/study/NCT04819347

Phase

Phase II

Status

Unknown status

Sponsor

Frontier Biotechnologies Inc.

More details

This is a phase 2 study to evaluate the safety and tolerability of combination therapy with Albuvirtide (ABT) and 3BNC117 in virologically suppressed subjects with HIV-1 infection and explore the potential of viral suppression and viral reservoir clearance after analytical treatment interruption (ATI).

Purpose

Albuvirtide in Combination With 3BNC117 in Virologically Suppressed Subjects With HIV-1 Infection

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2021-05-01

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2021-03-24

Estimated Primary Completion Date
2022-06-01

Estimated Completion Date
2022-12-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: 1. Males and females, age ≥18 years 2. For cohort 1: HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) within 6 months of primary HIV infection (PHI), having the document evidence of initial diagnosis of HIV-1 infection and initiation of ART therapy within 6 months of PHI. For cohort 2: Chronically HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) after 6 months of primary HIV infection (PHI), having the document evidence of initial diagnosis of HIV-1 infection and initiation of ART therapy after 6 months of PHI. 3. Plasma HIV-1 RNA \<50 copies/mL for at least 12 months prior to Screening Visit. An exception for a recorded HIV-1 RNA "blip" (e.g., transient HIV-1 RNA \>50 copies/mL) can be considere

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

24

Allocation

Not provided

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

ABL

Identifier

NCT03719664

Link

https://clinicaltrials.gov/study/NCT03719664

Phase

Phase II

Status

Unknown status

Sponsor

Frontier Biotechnologies Inc.

More details

The study is an adaptive, phase 2, multicenter, three-part study to establish the dosage, safety and antiviral activity of combination therapy with albuvirtide (ABT) and 3BNC117 as long-acting maintenance therapy in virologically suppressed subjects with HIV-1 infection.

Purpose

Albuvirtide and 3BNC117 as Long-Acting Maintenance Therapy in Virologically Suppressed Subjects

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2018-12-17

Anticipated Date of Last Follow-up
2021-09-28

Estimated Primary Completion Date
2022-12-01

Estimated Completion Date
2022-12-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * Potential subjects are required to meet all of the following criteria for enrollment into the study. 1. HIV-1 seropositive; 2. Males and females, age ≥18 years; 3. Receiving oral combination antiretroviral therapy for last 24 weeks; 4. No change in antiretroviral regimen within last 4 weeks prior to Screening Visit and in-between Screening Visit and First Treatment Visit with an exception that subjects on NNRTI-containing regimens will be allowed to switch to protease inhibitor- or integrase strand transferase inhibitor-based regimens and such change, if needed, should occur at least 4 weeks prior to cessation of oral antiretroviral therapy; 5. Subject has two or more potential alternative antiretroviral drug options available; 6. Plasma HIV-1 RNA \<50 c

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

80

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

ABT-3BNC117_203

Identifier

NCT04560569

Link

https://clinicaltrials.gov/study/NCT04560569

Phase

Phase II

Status

Unknown status

Sponsor

Frontier Biotechnologies Inc.

More details

The primary objectives are to assess the antiviral activity, clinical safety and tolerability parameters of albuvirtide/3BNC117 combination therapy in reducing HIV-1 viral load during the 1-week induction period treatment period.

Purpose

Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2021-11-30

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2021-09-28

Estimated Primary Completion Date
2022-11-01

Estimated Completion Date
2022-12-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: 1. Males and females, age ≥ 18 years; 2. HIV-1 seropositive with documented HIV-1 infection by official, signed, written history (e.g. Laboratory report) 3. Receiving a combination antiretroviral therapy (cART) (failing regimen) for at least 8 weeks before Screening and are willing to continue on the failing regimen during the Screening Phase and up to Day 14 of the Treatment Phase, OR have failed in the past 8 weeks of Screening, are off therapy and are willing to stay off therapy until Day 14 of the Treatment Phase; 4. Plasma HIV-1 RNA ≥ 1000 copies/mL at the Screening Visit and documented detectable viral load (HIV-1 RNA \>200 copies/ml) within the last 3 months prior to the Screening Visit; 5. Highly treatment-experienced HIV-infected patients with genotypic and/or

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

20

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

TALENT

Identifier

NCT02369965

Link

https://clinicaltrials.gov/study/NCT02369965

Phase

Phase III

Status

Completed

Sponsor

Frontier Biotechnologies Inc.

More details

The purpose of this study is to evaluate the efficacy and safety of albuvirtide combined with lopinavir-ritonavir (LPV/r) in HIV-1-infected patients who failed first-line antiretroviral therapy (ART).

Purpose

Test Albuvirtide in Experienced Patients

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2014-02-19

Anticipated Date of Last Follow-up
2021-09-28

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2018-04-02

Actual Completion Date
2018-04-02

Studied populations

Age Cohort

• Children
• Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: 1. 16-60 years old, male or female. 2. Those who meet the Diagnostic Criteria of AIDS and HIV Infection, the Health Industry Standard of the People's Republic of China (WS 293-2008). 3. Those who have been undergoing antiretroviral treatment with nucleosides and non-nucleoside reverse transcriptase inhibitors (NRTIs+NNRTIs) for at least 6 months. 4. HIV-RNA ≥ 1000 copies/mL. 5. Those who have no serious hepatic or renal functional impairment and other parameters are generally in the normal ranges according to the comprehensive physical examinations (including general physical examination, routine blood and urine tests, blood chemistry tests, ECG, etc.). 6. The subjects should have a full understanding of the objective, nature, methods of the trial and the possible reac

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

418

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

FB-ABWT-401

Identifier

NCT04006353

Link

https://clinicaltrials.gov/study/NCT04006353

Phase

Marketed

Status

Completed

Sponsor

Shanghai Public Health Clinical Center

More details

This study is designed to estimate the drug interaction between RIF and ABT. This will be a single-center, open-label, parallel study in healthy adult subjects.

Purpose

The Drug Interaction Between Albuvirtide (ABT) and Rifampin（RIF） in Healthy Adult Subjects

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-07-11

Anticipated Date of Last Follow-up
2021-09-23

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2019-09-30

Actual Completion Date
2019-12-03

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Males and females, age between 18 and 65 years； * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including physical examination, laboratory tests, Chest X-ray, abdominal B-ultrasound and ECG; No serious liver and kidney dysfunction, normal albumin value, and other indicators are in the normal range； * Subjects weighing ≥50 kg and their BMI within the range 18.5-27.0 kg/m\^2 (inclusive)； * Agrees not to consume alcohol during the study； * Both male and female subjects and their partners of childbearing potential agree to use contraception during the study； * Females of childbearing potential must have a negative serum pregnancy test at Screening visit prior to receiving the first dose of study drug； * ALT、AST、ALP and TB

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

24

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

Proprietary excipients used

No proprietary excipient used

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

No novel excipient or existing excipient used

Residual solvents used

No residual solvent used

Description

Stable albuvirtide compositions

Brief description

A liquid compositions and stable lyophilized compositions comprising albuvirtide, an HIV-1 fusion inhibitor. The present invention also provides the manufacturing process thereof and use of these compositions for the prevention, treatment or prophylaxis of diseases caused by HIV.

Representative patent

WO2020223906A1

Category

Not provided

Patent holder

Frontier Biotechnologies Co Ltd

Exclusivity

Not provided

Expiration date

November 7, 2027

Status

Ceased

Publications

Hu, C., Zhou, X., He, L., Zhu, X., Cao, Q., Dai, B., Su, J., Liu, H., Qin, J., Wang, J., & Zhu, B. (2026). Safety and Virological Outcomes of a Modified Albuvirtide Intensification Regimen with Standard ART in People with HIV. Infection and drug resistance, 19, 617345. https://doi.org/10.2147/IDR.S617345

Caiqin Hu — Infection and Drug Resistance - Dovepress — 2026-08-27

Summary: Safety profile of Albuvirtide therapy

Background: To control HIV-1 viral load and maintain optimal immune function, albuvirtide (ABT) combined with antiretroviral therapy (ART) is used in designated AIDS hospitals in China. However, the standard weekly 320-mg ABT injection regimen poses adherence-related challenges. This study explored the safety and virological outcomes of a modified ABT intensification regimen in people with HIV.

Methods: This single-arm, uncontrolled prospective cohort enrolled 20 people with HIV who received intravenous ABT 320 mg for three consecutive days every four weeks while continuing their baseline ART regimens. Peripheral blood samples were collected to measure alanine aminotransferase (ALT), aspartate aminotransferase (AST), triglyceride (TAG), cholesterol, CD4+ T-cell counts, HIV-RNA levels, and plasma ABT concentrations.

Results: No adverse events considered related to ABT were observed in this cohort. Pharmacokinetic analysis demonstrated sustained therapeutic exposure, with mean trough concentrations of 4.71 mg/L, 3.83 mg/L, and 4.53 mg/L at Weeks 4, 8, and 12, respectively, each exceeding 50-fold the IC9 0. During follow-up, mean HIV-RNA decreased from 1.65 log10 copies/mL at baseline to 0.59 log10 copies/mL at Week 12 (mean reduction: 1.06 log1 0 copies/mL; P = 0.0007). Among patients with baseline HIV-RNA above 20 copies/mL, the viral load decreased from 2.55 to 1.43 log10 copies/mL.

Conclusion: Preliminary results demonstrate that 4-week ABT antiviral intensification regimen is feasible and exhibits potential antiviral activity.

Zhou, Y., Qin, Y., Liu, X., Zhao, Q., Wang, M., Chen, Y., Li, Y., He, K., Li, X., Harypursat, V., Xie, D., & Chen, Y. (2026). Albuvirtide plus 3BNC117 provides a promising combination strategy for multidrug-resistant HIV-1 infection: a prospective, open-label, multicenter phase 2 trial. BMC infectious diseases, 26(1), 911. https://doi.org/10.1186/s12879-026-12987-3

Yihong Zhou — BMC Infectious Diseases — 2026-05-28

Summary: Safety and Efficacy Study of Albuvirtide + 3BNC117

Background: Albuvirtide (ABT), a fusion inhibitor, and 3BNC117, a broadly neutralizing antibody, were evaluated for efficacy and safety in combination with an optimized background regimen (OBR) in adults with multidrug-resistant (MDR) HIV-1.

Methods: In this phase 2 trial conducted in China via an international collaborative screening effort, we enrolled MDR HIV-1 patients with prior treatment failures and baseline viral loads > 1000 copies/mL. After a 6-day control period on existing therapy, participants received 3BNC117 on day 7 and ABT on days 7-9. On day 14, eligible patients were randomized 1:1 to Group A (ABT once weekly and 3BNC117 once every two weeks) or Group B (ABT and 3BNC117 once every two weeks), each with an OBR containing at least one fully active drug, for 24 weeks. The primary endpoint was the proportion with ≥ 0.5 log10 viral load reduction from day 7 to 14.

Results: Sixteen patients completed the study. Baseline mean viral load was 4.47 log10 copies/mL, and mean CD4 + T-cell count was 165 cells/µL. By day 14, 62.5% showed a ≥ 0.5 log10 reduction from day 7 (p = 0.012 vs. control), with a mean drop of 1.05 log10. At end of treatment (EOT), the mean decrease was 2.82 log10, and 87.5% had viral load < 50 copies/mL. Viral load < 50 copies/mL was seen in 75% of Group A and 100% of Group B. No deaths or serious ABT+3BNC117-related adverse events were reported.

Conclusions: In patients with MDR HIV-1 infection who have limited treatment therapeutic options, the combination of ABT+3BNC117 plus an OBR was observed to have significant antiviral activity during a 34-week study period.

Trial registration: Clinicaltrials.gov NCT04560569, Sep 23, 2020.

Su, B., Yao, C., Zhao, Q. X., Cai, W. P., Wang, M., Lu, H. Z., Chen, Y. Y., Liu, L., Wang, H., He, Y., Zheng, Y. H., Li, L. H., Chen, J. F., Yu, J. H., Zhu, B., Zhao, M., Sun, Y. T., Lun, W. H., Xia, W., Sun, L. J., … TALENT Study Team (2020). Efficacy and safety of the long-acting fusion inhibitor albuvirtide in antiretroviral-experienced adults with human immunodeficiency virus-1: interim analysis of the randomized, controlled, phase 3, non-inferiority TALENT study. Chinese medical journal, 133(24), 2919–2927. https://doi.org/10.1097/CM9.0000000000001273

Bin Su — Chinese Medical Journal — 2020-11-25

Background: Albuvirtide is a once-weekly injectable human immunodeficiency virus (HIV)-1 fusion inhibitor. We present interim data for a phase 3 trial assessing the safety and efficacy of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults already treated with antiretroviral drugs.

Methods: We carried out a 48-week, randomized, controlled, open-label non-inferiority trial at 12 sites in China. Adults on the World Health Organization (WHO)-recommended first-line treatment for >6 months with a plasma viral load >1000 copies/mL were enrolled and randomly assigned (1:1) to receive albuvirtide (once weekly) plus ritonavir-boosted lopinavir (ABT group) or the WHO-recommended second-line treatment (NRTI group). The primary endpoint was the proportion of patients with a plasma viral load below 50 copies/mL at 48 weeks. Non-inferiority was prespecified with a margin of 12%.

Results: At the time of analysis, week 24 data were available for 83 and 92 patients, and week 48 data were available for 46 and 50 patients in the albuvirtide and NRTI groups, respectively. At 48 weeks, 80.4% of patients in the ABT group and 66.0% of those in the NRTI group had HIV-1 RNA levels below 50 copies/mL, meeting the criteria for non-inferiority. For the per-protocol population, the superiority of albuvirtide over NRTI was demonstrated. The frequency of grade 3 to 4 adverse events was similar in the two groups; the most common adverse events were diarrhea, upper respiratory tract infections, and grade 3 to 4 increases in triglyceride concentration. Renal function was significantly more impaired at 12 weeks in the patients of the NRTI group who received tenofovir disoproxil fumarate than in those of the ABT group.

Conclusions: The TALENT study is the first phase 3 trial of an injectable long-acting HIV drug. This interim analysis indicates that once-weekly albuvirtide in combination with ritonavir-boosted lopinavir is well tolerated and non-inferior to the WHO-recommended second-line regimen in patients with first-line treatment failure.

Trial registration: ClinicalTrials.gov Identifier: NCT02369965; https://www.clinicaltrials.gov.Chinese Clinical Trial Registry No. ChiCTR-TRC-14004276; http://www.chictr.org.cn/enindex.aspx.

Additional documents

No documents were uploaded

Useful links

• Prescribing Information of Albuvirtide