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- || islatravir (MK-8591) / Merck (MSD)
PK/PD data, Journal: Pharmacokinetics of islatravir in participants with moderate hepatic impairment. (Pubmed Central) - Mar 5, 2025
P1
The clinical relevance of the overall modest changes in M4, ISL, and ISL-TP levels with moderate hepatic impairment will be contextualized once exposure response data from ongoing clinical studies are available to elucidate the thresholds for clinical efficiency. A single oral dose of ISL 60 mg was generally well tolerated in both groups.CLINICAL TRIALSThis study is registered with Clinicaltrials.gov as NCT04515641.
- | islatravir (MK-8591) / Merck (MSD)
Journal: Nonclinical and clinical characterization of the absorption, metabolism, and excretion of islatravir. (Pubmed Central) - Feb 13, 2025
The pharmacologically active islatravir triphosphate is the most abundant intracellular phosphorylated species, as shown by the results of ex vivo studies. This characterization of the absorption, metabolism, and elimination of islatravir in humans and nonclinical species supports its further development for the treatment of HIV-1.
- ||| MK-8507 / Merck (MSD), islatravir (MK-8591) / Merck (MSD)
Trial completion: Dose Ranging, Switch Study of Islatravir (ISL) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013] (clinicaltrials.gov) - Feb 12, 2025
P2, N=161, Completed, Sponsor: Merck Sharp & Dohme LLC
This characterization of the absorption, metabolism, and elimination of islatravir in humans and nonclinical species supports its further development for the treatment of HIV-1. Active, not recruiting --> Completed
- | islatravir (MK-8591) / Merck (MSD)
Journal: The effect of the foreign body response on drug elution from subdermal delivery systems. (Pubmed Central) - Feb 2, 2025
Active, not recruiting --> Completed Specifically, we investigated the pharmacokinetic impact of fibrotic encapsulation on a small molecule drug, islatravir (293
- || islatravir (MK-8591) / Merck (MSD)
P1 data, PK/PD data, Journal: A Phase 1 Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between Islatravir and Methadone in Participants on Stable Methadone Therapy. (Pubmed Central) - Jan 6, 2025
P1
Coadministration of a single dose of islatravir and methadone was generally well tolerated. Single-dose islatravir did not affect steady-state methadone pharmacokinetics in a clinically meaningful way.
- ||||||||| islatravir (MK-8591) / Merck (MSD)
Trial termination: Impower-024: Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024) (clinicaltrials.gov) - Dec 11, 2024
P3, N=494, Terminated, Sponsor: Merck Sharp & Dohme LLC
Single-dose islatravir did not affect steady-state methadone pharmacokinetics in a clinically meaningful way. Completed --> Terminated; Voluntarily terminated due to benefit/risk assessment.
- || islatravir (MK-8591) / Merck (MSD)
PK/PD data, Journal: Pharmacokinetics of Atorvastatin and Metformin after Coadministration with Islatravir in Healthy Adults. (Pubmed Central) - Nov 26, 2024
Coadministration of islatravir with atorvastatin and metformin was well tolerated. Overall, coadministration of atorvastatin and metformin with a single oral dose of islatravir did not have a clinically meaningful effect on the PK profiles of either drug.
- || MK-8507 / Merck (MSD), islatravir (MK-8591) / Merck (MSD)
Trial completion date, Trial primary completion date: Dose Ranging, Switch Study of Islatravir (ISL) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013] (clinicaltrials.gov) - Nov 19, 2024
P2, N=161, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Overall, coadministration of atorvastatin and metformin with a single oral dose of islatravir did not have a clinically meaningful effect on the PK profiles of either drug. Trial completion date: Dec 2024 --> Mar 2025 | Trial primary completion date: Dec 2024 --> Mar 2025
- |||||| Sunlenca (lenacapavir) / Gilead
Enrollment open: ISLEND-2: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (clinicaltrials.gov) - Nov 1, 2024
P3, N=600, Recruiting, Sponsor: Gilead Sciences
Trial completion date: Dec 2024 --> Mar 2025 | Trial primary completion date: Dec 2024 --> Mar 2025 Not yet recruiting --> Recruiting
- |||||| Sunlenca (lenacapavir) / Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment open: ISLEND-1: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 (clinicaltrials.gov) - Oct 29, 2024
P3, N=600, Recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- Pifeltro (doravirine) / Merck (MSD)
Reduction in estimated glomerular filtration rate (eGFR) observed with doravirine (DOR) is caused by inhibition of organic cation transporter 2 (OCT2) () - Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_473;
Our in vitro observations mechanistically illustrate that the reduction in creatinine-based eGFR calculations observed with DOR is caused by inhibition of renal creatinine transport by DOR and does not reflect a reduction in renal function. These findings are consistent with clinical data showing improvement in eGFR, when calculated using cystatin-C, in treatment-na
- Sunlenca (lenacapavir) / Gilead
Pharmacokinetics of oral islatravir (ISL) plus lenacapavir (LEN) given once weekly in an open?label, active?controlled, phase II study of virologically suppressed people with HIV?1 () - Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_369;
P2
LEN 300 mg QW resulted in efficacious LEN exposures, consistent with approved subcutaneous LEN. These results are consistent with previous model-based predictions and support ISL/LEN 2/300 mg QW dosing in phase III.
- Sunlenca (lenacapavir) / Gilead
Once-weekly islatravir plus lenacapavir in virologically suppressed PWH: week 48 safety, efficacy, and metabolic changes () - Oct 15, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_21;
P2
Adherence to this weekly oral dosing regimen was high. ISL+LEN has the potential to become the first weekly oral complete regimen for the treatment of HIV-1 infection.
- |||||||||| Sunlenca (lenacapavir) / Gilead
New P3 trial: ISLEND-2: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (clinicaltrials.gov) - Oct 8, 2024
P3, N=600, Not yet recruiting, Sponsor: Gilead Sciences
- |||||||||| Sunlenca (lenacapavir) / Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
New P3 trial: ISLEND-1: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 (clinicaltrials.gov) - Oct 8, 2024
P3, N=600, Not yet recruiting, Sponsor: Gilead Sciences
- || MK-8507 / Merck (MSD), islatravir (MK-8591) / Merck (MSD)
New P1 trial: A Study of MK-8507 and Islatravir (MK-8591) in Healthy Adult Participants (MK-8507-016) (clinicaltrials.gov) - Oct 1, 2024
P1, N=36, Completed, Sponsor: Merck Sharp & Dohme LLC
- | Preclinical, Journal: Comprehensive Database of HIV Mutations Selected During Antiretroviral In Vitro Passage Experiments. (Pubmed Central) - Sep 17, 2024
Mutations emerging from these experiments generally predict those observed in persons receiving the same ARV. However, there are notable differences in mutation frequencies between in vitro and in vivo settings.
- islatravir (MK-8591) / Merck (MSD)
Oral Islatravir in macaques decreases total lymphocytes and monocytes and is associated with immune dysregulation (Poster Exhibition) - Sep 10, 2024 - Abstract #HIVR4P2024HIVR4P_963;
This effect reverted after treatment cessation as observed in humans. Our findings documenting alterations of key gene expression pathways associated with immune regulation and inflammation provide the first insights on the mechanisms of ISL-induced lymphopenia.
- Drug-agnostic transcutaneously-refillable subdermal implant for ultra-long-acting delivery of antiretrovirals for HIV prevention (Limatambo 3/Channel 1) - Sep 10, 2024 - Abstract #HIVR4P2024HIVR4P_931;
Implant drug-agnosticity imparts flexibility for single- or multi-ARV delivery for PrEP or treatment, as well as combination with contraceptives, serving as a multiprevention technology. Importantly, cost of good analysis estimates drug-loaded implant could be as low as USD 36/year, substantiating clinical viability for adoption in low resource countries.
- | islatravir (MK-8591) / Merck (MSD)
Journal: Intracellular islatravir-triphosphate half-life supports extended dosing intervals. (Pubmed Central) - Sep 4, 2024
Islatravir was generally well tolerated with no drug-related adverse events observed. Islatravir-TP has a long intracellular t
- || Review, Journal: Current status of the small molecule anti-HIV drugs in the pipeline or recently approved. (Pubmed Central) - Aug 22, 2024
There is a considerable progress in the development of new anti-HIV drugs and the effort will continue since HIV infections has no cure or vaccine till now. Efforts are needed to reduce the toxicity of available drugs or discover new drugs with new classes which can delay the development of resistance.
- islatravir (MK-8591) / Merck (MSD)
Using deterministic computational PBPK modeling in IVR design and performance evaluation (Poster Exhibition) - Aug 9, 2024 - Abstract #HIVR4P2024HIVR4P_882;
Efforts are needed to reduce the toxicity of available drugs or discover new drugs with new classes which can delay the development of resistance. Computations here are for Islatravir loaded into silicone-resin CLIP
- islatravir (MK-8591) / Merck (MSD)
Safety and tolerability of oral islatravir (ISL) once-monthly (QM) as pre-exposure prophylaxis (PrEP) in cisgender men and transgender women at elevated risk for acquiring HIV-1 (Limatambo 2/Channel 2) - Aug 9, 2024 - Abstract #HIVR4P2024HIVR4P_53;
P3
Of 695 participants screened, 494 were randomized, treated (328 ISL, 166 control) and included in the analysis (4.5% were transgender, 41.7% white, 25.1% black/African American, 20.4% Asian); median age 27 (range 18-76) years. In cisgender men and transgender women at elevated risk of acquiring HIV-1, decreases in total lymphocyte counts observed with ISL 60mg QM were not associated with increased infection AEs and were followed by a trend of recovery after drug discontinuation.
- islatravir (MK-8591) / Merck (MSD)
Safety and tolerability of oral islatravir (ISL) once-monthly (QM) as pre-exposure prophylaxis (PrEP) in cisgender women at elevated risk for acquiring HIV-1 (Limatambo 2/Channel 2) - Aug 9, 2024 - Abstract #HIVR4P2024HIVR4P_49;
P3
BACKGROUND: Once-monthly oral PrEP options are needed to address challenges with adherence to daily regimens and the complexity of injectable PrEP options and its barriers to scale-up, and to meet research-identified ideal product profiles. In cisgender women at elevated risk of acquiring HIV-1, decreases in total lymphocyte counts observed with ISL 60mg QM were not associated with increased infection AEs and were followed by a trend of recovery after drug discontinuation.
- ||||||||| islatravir (MK-8591) / Merck (MSD)
Trial termination: Impower-022: Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022) (clinicaltrials.gov) - Aug 9, 2024
P3, N=730, Terminated, Sponsor: Merck Sharp & Dohme LLC
In cisgender women at elevated risk of acquiring HIV-1, decreases in total lymphocyte counts observed with ISL 60mg QM were not associated with increased infection AEs and were followed by a trend of recovery after drug discontinuation. Active, not recruiting --> Terminated; Voluntarily terminated due to benefit/risk assessment
- | Journal: Challenges for novel antiretroviral development in an era of widespread TLD availability. (Pubmed Central) - Jul 11, 2024
We illustrate when generic TLD will become available worldwide and compare this with trial programmes and approval timelines for two case-study novel ART combinations: islatravir/doravirine and cabotegravir/rilpivirine. We demonstrate that currently these regimens and trial programmes will not meet key benchmarks required to compete with TLD.
- || islatravir (MK-8591) / Merck (MSD)
Clinical, Journal: Thorough QT/QTc study to evaluate the effect of a single supratherapeutic dose of islatravir on QTc interval prolongation in healthy adults. (Pubmed Central) - Jul 2, 2024
The pharmacokinetic profile of islatravir was consistent with that of previous studies, and islatravir was generally well tolerated. Results from the current trial suggest that single doses of islatravir as high as 240 mg do not lead to QTc interval prolongation.
- | Sunlenca (lenacapavir) / Gilead, islatravir (MK-8591) / Merck (MSD)
Preclinical, Journal: No antagonism or cross-resistance and a high barrier to the emergence of resistance in vitro for the combination of islatravir and lenacapavir. (Pubmed Central) - Jun 12, 2024
The known pathways for development of resistance with ISL and LEN were not altered, and no novel single mutations emerged that substantially reduced susceptibility to either compound. The lack of antagonism and cross-resistance between ISL and LEN support the ongoing evaluation of the combination for treatment of HIV-1.
- ||| P3 data, Journal, Head-to-Head: Switch to fixed-dose doravirine (100 mg) with islatravir (0 (Pubmed Central) - May 30, 2024
P3
The lack of antagonism and cross-resistance between ISL and LEN support the ongoing evaluation of the combination for treatment of HIV-1. Switching to daily doravirine (100 mg) and islatravir (0
- ||| Pifeltro (doravirine) / Merck (MSD), doravirine/islatravir (MK-8591A) / Merck (MSD), islatravir (MK-8591) / Merck (MSD)
P3 data, Journal, Head-to-Head: Switch to fixed-dose doravirine (100 mg) with islatravir (0 (Pubmed Central) - May 30, 2024
P3
Switching to daily doravirine (100 mg) and islatravir (0 Switching to single-tablet doravirine (100 mg) and islatravir (0
- | islatravir (MK-8591) / Merck (MSD)
Journal: Is this the end of the road for daily islatravir 0 (Pubmed Central) - May 30, 2024
Switching to single-tablet doravirine (100 mg) and islatravir (0 No abstract available
- Monitoring the landscape of newer HIV medicines: multiple patenting and access challenges (Poster board: 647) - May 2, 2024 - Abstract #AIDS2024AIDS_3236;
The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
- Pifeltro (doravirine) / Merck (MSD), islatravir (MK-8591) / Merck (MSD)
Tenofovir and doravirine are potential reverse-transcriptase analogs for combination with the new reverse-transcriptase translocation inhibitor (Islatravir) among treatment-experienced patients in Cameroon: designing future treatment strategies for low- and middle-income countries (Poster board: 003) - May 2, 2024 - Abstract #AIDS2024AIDS_971;
The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
- | islatravir (MK-8591) / Merck (MSD)
Journal: Insights into Factors Affecting Ethylene-Vinyl Acetate Copolymer Crystallinity in Islatravir Implant. (Pubmed Central) - Apr 3, 2024
Furthermore, DSC analysis of thin implant slices prepared with an ultramicrotome indicated that the surface layer of the implant was more crystalline than the core. These findings provide critical insights into factors affecting the crystallinity, mechanical properties, and physicochemical properties of the EVA polymer matrix of extruded islatravir implants.
- Sunlenca (lenacapavir) / Gilead, islatravir (MK-8591) / Merck (MSD)
Efficacy and Safety of Weekly Islatravir Plus Lenacapavir in PWH at 24 Weeks: A Phase II Study () - Mar 16, 2024 - Abstract #CROI2024CROI_1164;
P2
In this Phase 2 study, the first QW oral ARV regimen of ISL+LEN maintained viral suppression at W24 and was well tolerated. The ISL 2 mg dose showed no clinically significant decreases in CD4+ T-cell counts or ALCs as were seen previously with higher daily, weekly, and monthly doses of ISL.
- MK-8527 / Merck (MSD)
Discovery of MK-8527: A Long-Acting HIV-1 Nucleoside Reverse Transcriptase Translocation Inhibitor (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_943;
Background: Nucleoside reverse transcriptase translocation inhibitors (NRTTIs) such as islatravir (ISL) are potent inhibitors of HIV-1 replication. The subnanomolar potency, absence of off-target activity, and suitable PK for at least once-weekly dosing make MK-8527 an attractive clinical candidate for prophylaxis of HIV-1 infection
- | islatravir (MK-8591) / Merck (MSD)
Journal: Antiviral potency of long-acting islatravir subdermal implant in SHIV-infected macaques. (Pubmed Central) - Mar 4, 2024
The ISL implant produced moderate reactivity in the surrounding tissue, indicating tolerability. Overall, we present the ISL subdermal implant as a promising approach for LA ARV treatment in PLWH.
- || islatravir (MK-8591) / Merck (MSD)
PK/PD data, Preclinical, Journal: Pharmacokinetic Modeling to Guide Preclinical Development of an Islatravir-Eluting Reservoir-Style Biodegradable Implant for Long-Acting HIV PrEP. (Pubmed Central) - Feb 24, 2024
Our zero-order ISL-release poly(?-caprolactone) implant is projected to achieve clinical PK above ISL-tp's PrEP efficacy threshold. Continued development for HIV PrEP applications is warranted.
- | islatravir (MK-8591) / Merck (MSD)
Journal: Islatravir: evaluation of clinical development for HIV and HBV. (Pubmed Central) - Jan 18, 2024
Additionally, MK-8527, which inhibits HIV via same mechanism as that of ISL may supersede ISL. Data on ISL inhibition of HBV are scarce, and preclinical data show dramatically lower ISL efficacy against HBV than currently preferred nucleos(t)ide drugs, indicating that ISL may not be a potent anti-HBV drug.
- | islatravir (MK-8591) / Merck (MSD)
Journal: Islatravir Dimer: Crystal Form Dependence of a Radiation-Induced Degradation Product. (Pubmed Central) - Jan 4, 2024
Additionally, this dimer is not observed to form under other forced stress conditions. We present the structural elucidation of this dimer impurity and rationalize its form-dependent generation based on the analysis of the underlying crystal structure.
- | islatravir (MK-8591) / Merck (MSD)
Journal: Variable antiviral activity of islatravir against M184I/V mutant HIV-1 selected during antiretroviral therapy. (Pubmed Central) - Dec 28, 2023
We present the structural elucidation of this dimer impurity and rationalize its form-dependent generation based on the analysis of the underlying crystal structure. Mutations and polymorphisms selected in vivo together with M184V/I depend on the viral genetic context and on ART history, and could affect the efficacy of islatravir once available for use in the clinic.
- || MK-8507 / Merck (MSD), islatravir (MK-8591) / Merck (MSD)
Phase classification, Trial completion date, Trial primary completion date: Dose Ranging, Switch Study of Islatravir (ISL) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013] (clinicaltrials.gov) - Dec 17, 2023
P2, N=161, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Mutations and polymorphisms selected in vivo together with M184V/I depend on the viral genetic context and on ART history, and could affect the efficacy of islatravir once available for use in the clinic. Phase classification: P2b --> P2 | Trial completion date: Dec 2023 --> Sep 2024 | Trial primary completion date: Dec 2023 --> Sep 2024
- | islatravir (MK-8591) / Merck (MSD)
Phase classification, Enrollment change, Trial withdrawal: Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043) (clinicaltrials.gov) - Nov 27, 2023
P2, N=0, Withdrawn, Sponsor: Merck Sharp & Dohme LLC
Phase classification: P2b --> P2 | Trial completion date: Dec 2023 --> Sep 2024 | Trial primary completion date: Dec 2023 --> Sep 2024 Phase classification: P2a --> P2 | N=175 --> 0 | Not yet recruiting --> Withdrawn
- | islatravir (MK-8591) / Merck (MSD)
Journal, Combination therapy: HIV-1 Resistance to Islatravir/Tenofovir Combination Therapy in Wild-Type or NRTI-Resistant Strains of Diverse HIV-1 Subtypes. (Pubmed Central) - Oct 28, 2023
We demonstrated that the S68G polymorphism can enhance fitness of drug-resistant mutants in some genetic backgrounds. Collectively, the data suggest that the opposing resistance profiles of ISL and TDF suggest that a combination of the two drugs could be a promising drug regimen for the treatment of patients infected with any HIV-1 subtype, including those who have failed 3TC/FTC-based therapies.
- islatravir (MK-8591) / Merck (MSD)
Investigational Studies to Understand the Decreases in Lymphocytes Seen Clinically with Islatravir (ISL) and Enabling the Initiation of New Clinical Trials (ePosters area) - Oct 8, 2023 - Abstract #EACS2023EACS_1562;
Mitochondrial toxicity is not a contributing mechanism. These investigations, together with clinical and modelling data, identified an ISL-TP threshold (9
- Pifeltro (doravirine) / Merck (MSD), islatravir (MK-8591) / Merck (MSD)
Switch to fixed-dose doravirine (100 mg) with islatravir (0.75 mg) once daily in adults with HIV-1 virologically suppressed on antiretroviral therapy: week 96 results of a randomized, open-label, phase 3 trial (ePosters) - Oct 8, 2023 - Abstract #EACS2023EACS_616;
P3
These investigations, together with clinical and modelling data, identified an ISL-TP threshold (9 Conclusions :
- Pifeltro (doravirine) / Merck (MSD), islatravir (MK-8591) / Merck (MSD)
Switch to fixed-dose doravirine (100 mg) with islatravir (0.75 mg) once daily in adults with HIV-1 virologically suppressed on antiretroviral therapy: week 96 results of a randomized, open-label, phase 3 trial (ePosters) - Oct 8, 2023 - Abstract #EACS2023EACS_615;
P3
Conclusions : Conclusions :
- || islatravir (MK-8591) / Merck (MSD)
Trial completion date, Trial primary completion date: Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043) (clinicaltrials.gov) - Sep 13, 2023
P2a, N=175, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
Conclusions : Trial completion date: Apr 2025 --> Oct 2025 | Trial primary completion date: Apr 2025 --> Oct 2025
- | islatravir (MK-8591) / Merck (MSD)
Journal: Biocatalytic cascade process of islatravir: Analytical and regulatory control strategy of minor enantiomer. (Pubmed Central) - Aug 28, 2023
Detail of designing key method validation components such as method linearity, precision and robustness is discussed, and their results were presented. The method was successfully validated to fulfill various expectation from each individual health authority including FDA, EMA, PMDA, and ANVISA.
- ||||||| islatravir (MK-8591) / Merck (MSD)
Trial completion: Impower-024: Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024) (clinicaltrials.gov) - Aug 21, 2023
P3, N=494, Completed, Sponsor: Merck Sharp & Dohme LLC
The method was successfully validated to fulfill various expectation from each individual health authority including FDA, EMA, PMDA, and ANVISA. Active, not recruiting --> Completed