Lenacapavir impurity analysis

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Abstract

On June 20, 2024, Gilead Sciences announced the interim results of the pivotal Phase 3 PURPOSE 1 trial for Lenacapavir, a new HIV prevention drug administered via subcutaneous injection twice a year, demonstrating 100% efficacy in preventing HIV infection in young women.
On August 22, 2022, the European Commission approved Lenacapavir globally for use in combination with other antiretroviral drugs to treat adult HIV-infected patients with multidrug-resistant virus who cannot achieve viral suppression.
The synthesis of the key intermediate LNKPW01 for Linaclotide involves the Suzuki reaction, during which we identified several impurities. Through in-depth investigation of these impurities, we gained a deeper understanding of the process. Let's take a closer look at these impurities, with impurity M being the most significant.

Keywords

Lenvatinib

Process

Impurities

References

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