Drug name
Last update: Sep 2026Lipovirtide (LP-80)
Developer(s)
Drug information
Not provided
Lipovirtide; LP-80; stearic acid (C18)-conjugated lipopeptide HIV-1/HIV-2 gp41 fusion inhibitor derived from the chimeric peptide template P-52
Not applicable (investigational; no brand name assigned)
Biotherapeutic
HIV fusion inhibitor (gp41 NHR-targeting lipopeptide)
Lipovirtide (originally designated LP-80) is a stearic acid (C18)-modified lipopeptide HIV-1/HIV-2 fusion inhibitor developed at the National Institute of Pathogen Biology, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS/PUMC), and taken into clinical development by Shanxi Kangbao Biological Product Co., Ltd. It is derived from the enfuvirtide (T-20)-based chimeric template P-52, in which the C-terminal tryptophan-rich motif is replaced by a fatty acid; the C18 conjugation anchors the inhibitor in the target cell membrane and extends its half-life. It blocks six-helix bundle formation by binding the gp41 N-terminal heptad repeat, thereby preventing virus-cell membrane fusion. Preclinically, LP-80 inhibited divergent HIV-1 subtypes with a mean IC50 of 5.58 pM.
Investigational. Not approved in any jurisdiction as of September 2026. Developed in China. Phase II (NCT06061536) completed; a phase III trial is reported in the peer-reviewed literature (Zhu et al., Antiviral Research 2026) but no corresponding registry record was located.
No marketing authorisation applications identified. Clinical development conducted in China under NMPA oversight; trials registered on ClinicalTrials.gov record that the product is not a US FDA-regulated drug.
Therapeutic area(s)
- HIV
- Treatment
Administration route
Subcutaneous
Associated long-acting platforms
Aqueous drug particle suspension, Lipopeptide (fatty acid-conjugated peptide), Monoclonal antibodies and antibody drug conjugates
Use of drug
- Administered by a nurse
- Administered by a specialty health worker
- Weekly
- Every 2 weeks
No published patient-reported acceptability data. In macaque studies no significant injection site reactions or systemic toxicity were observed. Human safety data from the completed phase I and phase II studies have not been published; no anti-drug antibodies were detected in rat or macaque studies.
Dosage
Investigational. Single-dose phase I evaluated 5, 10, 20, 40, 60 and 80 mg subcutaneously; phase II evaluated 10 mg and 40 mg once weekly and 60 mg once every 2 weeks.
80 mg (highest single dose evaluated in phase I, NCT04592315)
Investigational. No approved regimen. Phase II regimens under evaluation: lipovirtide 10 mg or 40 mg subcutaneously once weekly, or 60 mg once every 2 weeks, each combined with daily oral lamivudine (3TC) plus tenofovir disoproxil fumarate (TDF), compared with daily oral DTG + 3TC + TDF.
Doses listed are taken from trial registry arm descriptions, not from a product label. Preclinical macaque dosing was 3 mg/kg subcutaneously twice weekly.
Not provided
Associated compounds, formulations and regimens
Not provided
Associated technologies
Not provided
Additional information
Developer(s)
Drug structure
Scale-up and manufacturing prospects
Manufactured by solid-phase Fmoc peptide synthesis with C-terminal lysine side-chain deprotection for fatty acid conjugation at research scale; GMP scale-up capacity for the clinical product has not been disclosed.
Research-scale synthesis reported: solid-phase peptide synthesiser (Rink amide MBHA resin, Fmoc chemistry); hydrazine/DMF deprotection step for Dde-protected lysine; reverse-phase preparative HPLC for purification; mass spectrometer for characterisation; lyophiliser. Commercial-scale equipment list not reported.
Chemical synthesis (solid-phase peptide synthesis). Peptides N-terminally acetylated and C-terminally amidated; stearic acid conjugated at a C-terminal lysine side chain following Dde deprotection; purified by RP-HPLC to >95% homogeneity. GMP manufacturing details for the clinical product have not been published.
RP-HPLC; mass spectrometry; LC-MS/MS for plasma concentration measurement; circular dichroism spectroscopy for alpha-helicity and thermostability.
Excipients & delivery device(s)
Not provided
Not provided
Not provided
No delivery device
Safety, Efficacy and Evidence Summary
Not provided
Not provided
Not provided
Not provided
There are either no relevant patents or these were not yet submitted to LAPaL