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

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

A Clinical Trial of MK-8527 and Rifampin in Adult Participants With Latent Tuberculosis Infection (MK-8527-019) (clinicaltrials.gov) - P1 | N=14 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009) (clinicaltrials.gov) - P1 | N=13 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • 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 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

Targeted universalism for long-acting PrEP: an urgent need to avoid risk targeting and build population-level impact. (PubMed, Lancet HIV) - "New long-acting HIV prevention product choices, including lenacapavir, cabotegravir, and investigational monthly oral MK‑8527, usher in promise for ending HIV as a public health threat...Targeted universalism means setting the goal of universal access for anyone who wants effective prevention and then tailoring functional supports, such as convenient delivery points and improved provider capacity for supportive interactions, to: 1) guide distribution of limited supply, and 2) help groups facing the steepest barriers to engage with prevention on an equal footing. As a policy framework, targeted universalism thus seeks to avoid mistakes that have restricted the population-level impact of oral PrEP by eliminating epidemiologically driven risk targeting, reckoning with the social resistance associated with stigmatised interventions and populations, and facilitating equitable coverage through systems strengthening."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

The estimated cost of MK-8527 produced at scale for once-monthly oral HIV pre-exposure prophylaxis (PrEP) in low- and middle-income countries. (PubMed, AIDS) - "MK-8527 could be manufactured at extremely low cost, suggesting that intellectual property and licensing arrangements, rather than production feasibility, will determine equitable access in LMICs. Early voluntary licensing agreements could facilitate timely generic entry and affordable global scale-up if clinical efficacy is confirmed."

Journal • Human Immunodeficiency Virus • Infectious Disease

Antiretroviral Activity, Pharmacokinetics, and Safety of MK-8527, an Oral Nucleoside Reverse Transcriptase Translocation Inhibitor, in Adults Living With HIV-1 Who Had Not Previously Taken Antiretroviral Agents: Results From Two Open-Label, Phase 1 Studies. (PubMed, Clin Infect Dis) - P1 | "In adults living with HIV-1 who had not previously taken antiretroviral agents, single doses of MK-8527 as low as 0.5 mg achieved ≥1.0 log10 decreases in HIV-1 RNA at 7 days post-dose administration."

Journal • P1 data • PK/PD data • Human Immunodeficiency Virus • Infectious Disease