AlbuvirtideOther Names: ABT, FB006M Drug Class: Fusion Inhibitor Registry Number: 1417179-66-8 (CAS) Organization: Frontier Biotechnologies Co., Ltd Phase of Development: Albuvirtide is in Phase III development for HIV treatment. In June 2018, albuvirtide received marketing approval in China for the treatment of HIV.
(Compound details obtained from ChemIDplus Advanced,1 Treatment Action Group 2017 Pipeline Report,2 and Frontier Biotechnologies press release.3)
What is albuvirtide?
Albuvirtide is anthat is being studied to treat HIV .2
Albuvirtide belongs to a group of HIV drugs calledinhibitors. Fusion inhibitors block HIV from getting into and infecting certain cells of the . Albuvirtide works by attaching to a on the outer surface of HIV. This protein is called the protein. By attaching to the gp41 envelope protein, albuvirtide blocks HIV from getting into and infecting immune cells.4
Which clinical trials are studying albuvirtide?
Study Name: ChiCTR-TRC-13003140
Status: This study has been completed.
Purpose: The purpose of this study was to evaluate 1) the drug-drug interactionbetween albuvirtide and the FDA-approved lopinavir/ritonavir (brand name: Kaletra) and 2) the short-term safety and effectiveness of albuvirtide plus lopinavir/ritonavir.5
Study Names: TALENT; NCT02369965
Status: The status of this study is unknown.
Purpose: The purpose of this study is to determine the safety and effectiveness of albuvirtide plus lopinavir/ritonavir.6,7
For more details on the studies listed above, see the Health Professional version of this drug summary.
The company developing albuvirtide also plans to study albuvirtide plus 3BNC117 as a 2-drug regimen for treating HIV. A Phase II trial investigating this combination will be conducted in the United Sates.8
What side effects might albuvirtide cause?
One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of albuvirtide listed above.
In this Phase II study, none of the participants had serious side effects. They did have some mild side effects related to albuvirtide, including nausea, diarrhea, rash, and increased triglyceride levels.5
In this Phase III study, 6 participants receiving albuvirtide had a serious side effect, but none of them were related to albuvirtide. Overall, the most commonly reported side effects associated with albuvirtide were mild to moderate diarrhea, headache, and dizziness. Among participants receiving albuvirtide, the most common abnormal blood test results were high and increased triglyceride levels.6
Because albuvirtide is still being studied, information on possible side effects of the drug is not complete. As testing of albuvirtide continues, additional information on possible side effects will be gathered.
Where can I get more information about clinical trials studying albuvirtide?
More information about albuvirtide-related research studies is available from the AIDSinfo database of study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.
Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a NIH Clinical Research Trials and You.is right for you. For information, visit
- United States National Library of Medicine. ChemIDplus Advanced: Albuvirtide. https://chem.nlm.nih.gov/chemidplus/rn/1417179-66-8. Accessed October 4, 2018.
- Frick M, Gaudino A, Harrington M, et al. Treatment Action Group. 2017 pipeline report. http://www.pipelinereport.org/sites/default/files/2017%20Pipeline%20Report%20Final.pdf. Published July 2017. Accessed October 4, 2018.
- Frontier Biotechnologies, Inc. Press release, dated June 7, 2018. Frontier Biotech receives marketing authorization from China FDA for Aikening® (albuvirtide for injection), China’s first new drug for the treatment of HIV. http://www.frontierbiotech.com/en/news/details_11_43.html. Accessed October 4, 2018.
- Chong H, Yao X, Zhang C, et al. Biophysical property and broad anti-HIV activity of albuvirtide, a 3-maleimimidopropionic acid-modified peptide fusion inhibitor. PLoS ONE. 2012;7(3). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3293837/. Accessed October 4, 2018.
- Zhang H, Jin R, Yao C, et al. Combination of long-acting HIV fusion inhibitor albuvirtide and LPV/r showed potent efficacy in HIV-1 patients. AIDS Res Ther. 2016;13. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4748529/. Accessed October 4, 2018.
- Xie D. Efficacy and safety of long acting HIV fusion inhibitor albuvirtide in antiretroviral-experienced adults with HIV-1: interim 48 week results from the randomized, controlled, phase 3, non-inferiority TALENT study. Webcast presented at: International Congress of Drug Therapy in HIV Infection (HIV Glasgow); October 23-26, 2016; Glasgow, United Kingdom. https://vimeo.com/189136480. Accessed October 4, 2018.
- Frontier Biotechnologies Co., Ltd. Efficacy and safety of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults failed standard first-line ART regimen. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on February 24, 2015. NLM Identifier: NCT02369965. https://clinicaltrials.gov/ct2/show/NCT02369965. Accessed October 4, 2018.
- Frontier Biotechnologies, Inc. Press release, dated August 21, 2018. Frontier Biotech’s novel long-acting, all-injectable anti-HIV two-drug combo IND allowed by the US FDA. http://www.frontierbiotech.com/en/news/details_11_44.html. Accessed October 4, 2018.
Last Reviewed: October 4, 2018