Drug name
Last update: Oct 2026LP-98
Drug information
Not provided
LP-98
Not applicable (investigational; no brand name assigned)
Biotherapeutic
Fusion inhibitor
LP-98 is a lipopeptide-based HIV-1 fusion inhibitor that binds the N-terminal heptad repeat of gp41 and blocks virus-cell membrane fusion. It belongs to the LP series of lipopeptides developed at the Institute of Pathogen Biology, Chinese Academy of Medical Sciences, the same series as LP-80 (lipovirtide), and is being developed clinically by Shanxi Kangbao Biological Product Co., Ltd. In SHIV-infected rhesus macaques, low-dose monotherapy sharply reduced viral load and maintained long-term suppression, and a single injection of a microsphere formulation sustained antiviral activity for at least 28 days; preclinical work also showed pre-exposure prophylaxis activity against SHIV and SIV. Clinical development is in China: a first-in-human phase 1 study compared single subcutaneous and intravenous doses in healthy adults, a completed phase 1/2 study gave four subcutaneous doses at 14-day intervals to treatment-naive adults with HIV, and an exploratory phase 1/2 study is under way in Tianjin. The long dosing interval studied so far is every 2 weeks; reduced activity against enfuvirtide-resistant strains carrying mutations in the gp41 NHR has been reported.
Not approved in any jurisdiction as of October 2026. Clinical development in phase 1/2 in China only.
Not approved in any jurisdiction as of October 2026.
Therapeutic area(s)
- HIV
- Treatment
Administration route
Subcutaneous, Intravenous
Associated long-acting platforms
Polymer-based particles
Use of drug
- Administered by a nurse
- Administered by a specialty health worker
- To be determined
- Every 2 weeks
Dosage
Investigational. Healthy volunteers: SC 5, 10, 20, 40,80 mg; IV 5, 10, 20, 40, 80,160 mg. Adults with HIV: SC 1.25, 2.5, 5, 10 mg every 2W (multiple-dose study) and 20, 40, 80 mg (exploratory study).
160 mg intravenous (single dose, healthy volunteers); 80 mg SC
No approved regimen. Multiple-dose phase 1/2 study: subcutaneous injection every 14 days, 4 doses in total, at 1.25, 2.5, 5 or 10 mg.
Activity is reduced against enfuvirtide (T20)-resistant HIV-1 carrying single or double mutations in the gp41 N-terminal heptad repeat.
Not provided
Related entries
Not provided
Additional information
Developer(s)
Shanxi Kangbao Biological Product Co., Ltd.
Institute of Pathogen Biology, Chinese Academy of Medical Sciences, Beijing
Drug structure
Scale-up and manufacturing prospects
Not reported for this product. Standard synthetic lipopeptide considerations apply: solid-phase peptide synthesis yield and purification, lipid conjugation, solubility and stability of the injectable solution.
Not reported for this product. Solid-phase peptide synthesis, preparative reversed-phase HPLC purification, lyophilisation and aseptic fill-finish may be assumed.
Synthetic lipopeptide. Process details not published. Developed by Shanxi Kangbao Biological Product Co., Ltd. with the Institute of Pathogen Biology, Beijing.
Not reported for this product. Standard peptide characterisation applies: reversed-phase HPLC for purity, mass spectrometry for identity, circular dichroism for secondary structure.
Excipients & delivery device(s)
Not provided
Not provided
Not provided
No delivery device
Safety, Efficacy and Evidence Summary
No peer-reviewed clinical safety data identified. Immunogenicity (anti-drug antibodies) is an endpoint in both the first-in-human and the multiple-dose studies. Public disclosure of results is pending.
No clinical efficacy results published to date. Preclinical: monotherapy with a low dose of LP-98 sharply reduced viral load and maintained long-term suppression in 21 SHIV-SF162P3-infected rhesus macaques.
Not provided
Not provided
There are either no relevant patents or these were not yet submitted to LAPaL