Drugs / RISLENEMDAZ
last change Nov 2019 re-read 9 days ago

RISLENEMDAZ

also known as MK-0657 · CERC-301

Small molecule

Developed for
major depressive disorder · Parkinson disease
Investigated by
Avalo Therapeutics, Inc. · Merck Sharp & Dohme LLC · National Institute of Mental Health (NIMH)

Trials 4

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials · 2 missed
Phase 1 NCT00472576 May 2007 → Aug 2009 major depressive disorder National Institute of Mental Health (NIMH) Completed Missed primary
Phase 1 NCT00505843 May 2007 → Feb 2008 Parkinson disease Merck Sharp & Dohme LLC Completed Missed primary
Phase 22 trials
Phase 2 NCT02459236 Jun 2015 → Sep 2016 major depressive disorder Avalo Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT01941043 Nov 2013 → Sep 2014 major depressive disorder Avalo Therapeutics, Inc. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2019-07-01 Avalo Therapeutics, Inc. Results Cerecor Announces Positive Final Results of CERC-301 in the Treatment of Neurogenic Orthostatic Hypotension (OH) July 01, 2019 6:30am EDT avalotx.com ↗
These final results further strengthen the previously reported interim results, showing that CERC-301 produces a rapid, robust and sustained improvement in systolic blood pressure (SBP) upon standing in Parkinson’s patients suffering from nOH, utilizing the standardized Orthostatic Standing Test (OST).
2019-04-15 Avalo Therapeutics, Inc. Results Cerecor Announces Positive Interim Results of CERC-301 in the Treatment of Neurogenic Orthostatic Hypotension (nOH) April 15, 2019 6:30am EDT avalotx.com ↗
The top-line results demonstrate a rapid, robust increase in systolic blood pressure (SBP) from baseline to 6 hours.
2016-11-29 Avalo Therapeutics, Inc. Results Cerecor Reports Top-Line Data from CERC-301 Phase 2 Study for Major Depressive Disorder November 29, 2016 4:01pm EST avalotx.com ↗
Overall, the trial failed to demonstrate efficacy on the primary endpoint for mean improvement in Bech-6, a subset of the Hamilton Depression Scale (HDRS-17), averaged over days 2 and 4 post dose.
2016-01-19 Avalo Therapeutics, Inc. Results Cerecor Announces Publication Describing Antidepressant Activity of CERC-301 in Preclinical Model January 19, 2016 9:10am EST avalotx.com ↗
This publication reports results of CERC-301 in an acute preclinical depression model known as the forced swim test, a common model of antidepressant efficacy.

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as RISLENEMDAZ ChEMBL registry synonym — accepted as the source's own label CHEMBL2068839 ↗
Known as CERC-301 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01941043 ↗
1

NCT02459236 ↗

Known as MK-0657 “Single-dose administration of MK-0657, an NR2B-selective NMDA antagonist, does not result in clinically meaningful improvement in motor function in patients with moderate...” PMID 19491335 ↗ Jun 2009
2

NCT00472576 ↗

NCT00505843 ↗

Action Inhibit “selective NR2B antagonist (MK-0657, 4-8 mg/day given orally)” NCT00472576 ↗
Modality Small molecule — CHEMBL2068839 ↗
Route Oral “MK-0657, 4-8 mg/day given orally” NCT00472576 ↗