alimatravir (MK-8527) / Merck (MSD) - LARVOL DELTA

Phase 1 study to evaluate the effect of a single supratherapeutic dose of MK-8527 on QTc interval prolongation in healthy adults (HIV-Glasgow 2026) - No abstract available

Clinical • P1 data

EXPrESSIVE-10: a phase 3 study evaluating MK-8527 oral once monthly for HIV pre-exposure prophylaxis in cisgender women who are at greater likelihood of HIV exposure (HIV-Glasgow 2026) - No abstract available

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

EXPrESSIVE-11: a phase 3 study evaluating MK-8527 oral once monthly for HIV pre-exposure prophylaxis in cisgender men who have sex with men, transgender women, transgender men and gender nonbinary individuals who are at greater likelihood of HIV exposure (HIV-Glasgow 2026) - No abstract available

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) (clinicaltrials.gov) - P3 | N=4580 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) (clinicaltrials.gov) - P3 | N=4580 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P3 trial • Human Immunodeficiency Virus • Infectious Disease

EXPrESSIVE-18: A Clinical Study of Alimatravir (MK-8527) in Transgender (Trans) and Gender Diverse Individuals on Gender-affirming Hormone Therapy and at Low Likelihood of Human Immunodeficiency Virus (HIV)-1 Exposure (MK-8527-018) (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P2 trial • Human Immunodeficiency Virus • Infectious Disease

Alimatravir Oral Once Monthly in Adults With Low Likelihood of HIV Exposure: A Randomized, Double-Blind, Placebo-Controlled Study. (PubMed, J Infect Dis) - P2 | "The favorable safety, tolerability, and pharmacokinetics of alimatravir and alimatravir-triphosphate support continued development of alimatravir as oral monthly pre-exposure prophylaxis."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease

A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021) (clinicaltrials.gov) - P1 | N=44 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) (clinicaltrials.gov) - P3 | N=4390 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

Phase 1 Study to Evaluate the Absorption, Metabolism, and Excretion of MK-8527, a Nucleoside Reverse Transcriptase Translocation Inhibitor, in Adults Without HIV (IDWeek 2026) - No abstract available

Clinical • P1 data • Human Immunodeficiency Virus • Infectious Disease

Stereoselective Synthesis of MK-8527 Enabled by a Dynamic Kinetic Resolution Mitsunobu Glycosylation. (PubMed, Org Lett) - "The key discoveries are a novel stereoselective dynamic kinetic resolution (DKR) Mitsunobu glycosylation and selective amination of the resulting 2,6-dichloro nucleoside. The new route was successfully demonstrated on the kilogram scale and provided isolated MK-8527 with more than 99% HPLC purity through crystallization."

Journal • Human Immunodeficiency Virus • Infectious Disease

A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527-020) (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion

A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527-020) (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

Improving transparency on patenting strategies of HIV medicines candidates to anticipate access challenges (AIDS 2026) - " Based on monitoring of clinical trials for new HIV antiretrovirals (ARVs), the following compounds were selected: GS-1614; GS-6212; GS-5894; GS-4182; GS-1720, VH4011499; VH4004280; VH4367310; VH-310; VH4524184; MK-8527; MK-850, islatravir... The findings have shown the multiple patenting on key antiretrovirals – reflecting the evergreening strategy - and an initial patent filing for newer compounds, allowing national-level monitoring by MMA members, and anticipating patent applications to be challenged. However, the lack of transparency of chemical structures has hindered the ability to develop an accurate patent landscape, which is an access challenges to promising candidates in the drug pipeline."

Human Immunodeficiency Virus • Infectious Disease

MK-8527 de novo resistance selection in HIV-1 subtypes A, B, and C and prevalence of M184I/V mutations in persons diagnosed with HIV without a known history of HIV treatment (AIDS 2026) - "Decreased viral fitness associated with M184I/V may contribute to its low prevalence in the non-PrEP group, indicating rare transmission. The wide range in the PrEP group may include acquired resistance with PrEP use in acute or unrecognized HIV acquisition. Therefore, although MK-8527 has reduced potency against virus with M184I/V mutations, impact to PrEP is not expected."

Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease

MK-8527 updates (AIDS 2026) - "Organized by IAS - the International AIDS Society"

Human Immunodeficiency Virus • Infectious Disease

Rigorous patentability criteria as a strategy for mitigating the negative impacts of intellectual property on health: a comparative study of long-acting antiretrovirals patent applications in Latin America’s largest economies (AIDS 2026) - " This is a cross-sectional study that investigated patent applications related to cabotegravir (CAB), rilpivirine (with CAB), lenacapavir (LEN) and MK-8527 in Latin America’s five largest economies (based on nominal Gross Domestic Product): Brazil, Mexico, Argentina, Chile and Colombia. Implementing rigorous national patentability criteria can be an effective strategy to prevent monopolies on essential drugs. Argentina exhibits a more access-favorable landscape than the other studied countries: despite the 14 patent applications for the selected LA ARVs, only MK-8527 is currently under patent protection."

Human Immunodeficiency Virus • Infectious Disease

Patent evergreening on long-acting HIV technologies (AIDS 2026) - " Based on oversight of clinical trials and regulatory approvals, the following compounds were selected: lenacapavir (LEN), cabotegravir (CAB), rilpivirine (RIL), islatravir (ISL) and MK-8527. The findings reveal that companies and academic institutions are pursuing patent protection for long-acting HIV technologies, with potential to extend or establish a monopoly over them. This will delay market entry of generics in countries where these applications are filed and granted. The potential public health benefits of these technologies should be addressed, including through use of TRIPS flexibilities, such as patent oppositions, compulsory licences and a public health perspective for patent examination."

Human Immunodeficiency Virus • Infectious Disease

Open-label phase 1 study of the effects of emtricitabine/tenofovir disoproxil fumarate on the pharmacokinetics of MK-8527, a nucleoside reverse transcriptase translocation inhibitor, in adults without HIV (AIDS 2026) - P1 | "FTC/TDF administered 24 hours before MK-8527 led to a minor reduction in MK-8527-TP AUC 0-inf, but C trough levels at 4 weeks (672 hours) were similar. MK-8527 was generally well tolerated when given alone or following multiple daily doses of FTC/TDF. Table."

Clinical • P1 data • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • DCK

Advancing a multi-year subdermal antiretroviral delivery implant towards clinical assessment for HIV pre-exposure prophylaxis, treatment and multipurpose prevention (AIDS 2026) - "Leveraging previous NanoDDI data demonstrating 29 months of sustained islatravir (ISL) delivery and 100% preventive efficacy in non-human primates (NHPs), we expanded the platform to deliver MK-8527, lenacapavir (LEN), bictegravir (BIC), tenofovir alafenamide (TAF), and levonorgestrel (LNG) for clinical translation in PrEP, treatment, and multipurpose prevention. NanoDDI provides multi-year long ARV delivery, maintaining protective levels and showing efficacy against SHIV in NHPs. This technology is now being advanced for first-in-human studies."

Clinical • First-in-human • Human Immunodeficiency Virus • Infectious Disease • Inflammation • NLRP3

Open-label phase 1 study to characterize the effects of a strong CYP3A4 inducer on the pharmacokinetics of MK-8527, a nucleoside reverse transcriptase translocation inhibitor, in adults without HIV (AIDS 2026) - P1 | "MK-8527 was generally well tolerated when given alone or with carbamazepine. The plasma pharmacokinetics of MK-8527 with or without administration of carbamazepine, a strong CYP3A4 inducer, were similar. Table."

Clinical • P1 data • PK/PD data • Human Immunodeficiency Virus • Immunology • Infectious Disease • CYP3A4

Alimatrevir: Mass production for $3 per year (AIDS 2026) - "BACKGROUND: Merck MK-8527 is a nucleoside reverse transcriptase translocation inhibitor (NRTTI), similar in structure to islatravir. The NRTTI MK-8527 could be mass produced for only $15ppy. Low unit prices could allow highly cost-effective mass distribution of MK-8527 as PrEP in LMICs for significantly less than either oral generic TDF/FTC or long-acting lenacapavir (both currently $40/year). Monthly MK-8527 could also offer important delivery advantages over daily oral or injectable formulations, particularly in resource-constrained settings."

A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021) (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open

A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021) (clinicaltrials.gov) - P1 | N=44 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527-020) (clinicaltrials.gov) - P1 | N=14 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open