MK-1942 / Merck (MSD) - LARVOL DELTA

Next-Generation Pharmacotherapies for Unipolar Mood Disorders: A Leading Article on Phase II/III Drug Development Across Diverse Mechanisms. (PubMed, CNS Drugs) - "Following the US Food and Drug Administration (FDA) approval of esketamine and brexanolone in 2019, industry investment in therapeutics with novel mechanisms for mood and anxiety disorders has expanded, catalyzing a new wave of innovative interventions...The drug names discussed are ALTO-100, ALTO-203, ALTO-207, ALTO-300, BHV-7000, BI-1569912, BPL-003, COMP360, DT120, ELE-101, GATE-251, GH001, GM-1020, GM-2505, HLP003, MK-1942, NBI-1065845, NBI-1070770, NV-5138, PIPE-307, SEP-363856, SPT-300, VLS-01, and XEN1101. The US Clinical Trials registry (clinicaltrials.gov), MEDLINE, conference proceedings, and company communications such as press releases were consulted to obtain up-to-date trial information and reported outcomes. Overall, the therapeutic landscape shows an expanding range of clinical compounds under active development; nonetheless, persistent challenges remain, including approaches to therapeutics where functional unblinding may occur, the ways in which to..."

Journal • P2/3 data • Review • CNS Disorders • Mood Disorders • Psychiatry

The Randomization Effect in a Double-Blind Placebo-Controlled Depression Study. (PubMed, J Clin Psychopharmacol) - "These post hoc results suggest an early randomization effect may complicate the interpretation of studies that examine treatment effects of drugs in development. Masking the timing of randomization with blinded, placebo-lead-in designs may warrant consideration for depression studies, particularly for rapid-acting antidepressants."

Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Phase 2 Clinical Trial of MK-1942, a Negative Allosteric Modulator of Metabotropic Glutamate Receptor 2, for Treatment-Resistant Depression. (PubMed, J Clin Psychopharmacol) - P2 | "Although interpretation of the findings is limited by the early termination of the trial, MK-1942 was not effective in treatment-resistant depression."

Clinical • Journal • P2 data • CNS Disorders • Depression • Mood Disorders • Psychiatry

Efficacy and Safety of MK-1942 as an Adjunct Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia (MK-1942-008) (clinicaltrials.gov) - P2 | N=99 | Terminated | Sponsor: Merck Sharp & Dohme LLC | Phase classification: P2a/2b ➔ P2

Phase classification • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006) (clinicaltrials.gov) - P2 | N=99 | Terminated | Sponsor: Merck Sharp & Dohme LLC | Phase classification: P2a ➔ P2

Phase classification • CNS Disorders • Depression • Mood Disorders • Psychiatry

Efficacy and Safety of MK-1942 as an Adjunct Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia (MK-1942-008) (clinicaltrials.gov) - P2a/2b | N=99 | Terminated | Sponsor: Merck Sharp & Dohme LLC | N=408 ➔ 99 | Active, not recruiting ➔ Terminated; Voluntarily terminated due to benefit/risk assessment

Enrollment change • Trial termination • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006) (clinicaltrials.gov) - P2a | N=99 | Terminated | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jan 2024 ➔ Sep 2023 | Recruiting ➔ Terminated | Trial primary completion date: Jan 2024 ➔ Sep 2023; Voluntarily terminated due to benefit/risk assessment

Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Depression • Mood Disorders • Psychiatry

Efficacy and Safety of MK-1942 as an Adjunct Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia (MK-1942-008) (clinicaltrials.gov) - P2a/2b | N=408 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: May 2025 ➔ Sep 2023 | Trial primary completion date: May 2025 ➔ Sep 2023

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Efficacy and Safety of MK-1942 as an Adjunct Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia (MK-1942-008) (clinicaltrials.gov) - P2a/2b | N=408 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Efficacy and Safety of MK-1942 as an Adjunct Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia (MK-1942-008) (clinicaltrials.gov) - P2a/2b | N=408 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: May 2026 ➔ May 2025 | Trial primary completion date: May 2026 ➔ May 2025

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006) (clinicaltrials.gov) - P2a | N=140 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Aug 2024 ➔ Jan 2024 | Trial primary completion date: Aug 2024 ➔ Jan 2024

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006) (clinicaltrials.gov) - P2a | N=140 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Sep 2023 ➔ Aug 2024 | Trial primary completion date: Sep 2023 ➔ Aug 2024

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

Efficacy and Safety of MK-1942 as an Adjunct Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia (MK-1942-008) (clinicaltrials.gov) - P2a/2b | N=408 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Efficacy and Safety Trial of MK-1942 in Participants with Alzheimer’s Disease dementia (MK-1942-008) Eficacia y seguridad del estudio MK-1942 en participantes con demencia por enfermedad de Alzheimer (MK-1942-008). (clinicaltrialsregister.eu) - P2 | N=408 | Ongoing | Sponsor: Merck Sharp & Dohme LLC

New P2 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005) (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders

MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005) (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders

Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006) (clinicaltrials.gov) - P2a | N=140 | Recruiting | Sponsor: Merck Sharp & Dohme Corp. | Trial completion date: Aug 2024 ➔ Sep 2023 | Trial primary completion date: Aug 2024 ➔ Sep 2023

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006) (clinicaltrials.gov) - P2a | N=140 | Recruiting | Sponsor: Merck Sharp & Dohme Corp. | Trial completion date: Nov 2023 ➔ Aug 2024 | Trial primary completion date: Nov 2023 ➔ Aug 2024

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005) (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Merck Sharp & Dohme Corp.; Trial completion date: Dec 2021 ➔ May 2022; Trial primary completion date: Dec 2021 ➔ May 2022

Clinical • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006) (clinicaltrials.gov) - P2a; N=140; Recruiting; Sponsor: Merck Sharp & Dohme Corp.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Depression • Mood Disorders • Psychiatry

Novamind Partners with Merck for New Treatment-Resistant Depression Trial (Issuer Direct) - "Novamind Inc....is pleased to announce that its wholly-owned subsidiary, Cedar Clinical Research ('CCR') has been selected as a key research site for a clinical trial focused on treatment-resistant depression by Merck & Co....The phase II study will assess the efficacy and safety of a new Merck drug for treatment-resistant depression...The clinical trial begins enrolling individuals in March 2021."

Enrollment status • Licensing / partnership • CNS Disorders • Depression

MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005) (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Merck Sharp & Dohme Corp.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Alzheimer's Disease • CNS Disorders

Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006) (clinicaltrials.gov) - P2a; N=140; Not yet recruiting; Sponsor: Merck Sharp & Dohme Corp.

Clinical • New P2a trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005) (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Merck Sharp & Dohme Corp.; Trial completion date: May 2021 ➔ Sep 2021; Initiation date: Oct 2020 ➔ Feb 2021; Trial primary completion date: May 2021 ➔ Sep 2021

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005) (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Merck Sharp & Dohme Corp.; Trial completion date: Nov 2020 ➔ May 2021; Initiation date: Apr 2020 ➔ Oct 2020; Trial primary completion date: Nov 2020 ➔ May 2021

Clinical • Trial completion date • Trial initiation date • Trial primary completion date