5-HT1A receptor antagonists(Serotonin 1a (5-HT1a) receptor antagonists), 5-HT1D receptor agonists(Serotonin 1d (5-HT1d) receptor agonists), MTNR1A agonists(Melatonin receptor 1A agonists)

Therapeutic Areas

Nervous System Diseases

Active Indication

Alzheimer Disease

Inactive Indication

Sleep Initiation and Maintenance Disorders

Originator Organization

Neurim Pharmaceuticals Ltd.

Active Organization

Neurim Pharmaceuticals Ltd.

Inactive Organization-

Drug Highest PhasePhase 2/3

First Approval Date-

Regulation-

Structure

Molecular FormulaC17H16N2O4

InChIKeyPNTNBIHOAPJYDB-UHFFFAOYSA-N

CAS Registry946846-83-9

Clinical Trials associated with Piromelatine

NCT05267535 / Active, not recruitingPhase 2/3

Randomized, Delayed Start, Double Blind, Parallel Group, Placebo Controlled, Multicenter Study of Piromelatine 20 mg in Participants With Mild Dementia Due to Alzheimer's Disease

Randomized efficacy and safety study of piromelatine 20 mg versus placebo in participants with mild dementia due to Alzheimer's disease (AD) who are 2:107,510,000-107,540,000 polymorphism non-carriers with the primary objective to compare the effect of piromelatine to that of placebo on the AD Assessment Scale cognitive subscale (ADAS-cog14) at Week 26 of double-blind treatment.

Start Date12 May 2022

Sponsor / Collaborator

Neurim Pharmaceuticals Ltd.

[+1]

EUCTR2016-002281-31-ES / Not yet recruitingPhase 2

A randomized, double-blind, placebo-controlled, study of oral treatment of piromelatine in patients with ocular hypertension (OHT) or primary open angle glaucoma (POAG).

Start Date19 Sep 2016

Sponsor / Collaborator

Neurim Pharmaceuticals Ltd.

NCT02615002 / CompletedPhase 2

Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Ranging Study of Piromelatine in Patients With Mild Dementia Due to Alzheimer's Disease

This study is a Phase 2, randomized, placebo controlled, dose ranging study of piromelatine (5, 20, and 50 mg daily for 6 months) versus placebo to determine an effective dose based on efficacy (cognitive performance), safety and tolerability in patients with mild dementia due to AD.

Start Date01 Nov 2015

Sponsor / Collaborator

Neurim Pharmaceuticals Ltd.

100 Clinical Results associated with Piromelatine

100 Translational Medicine associated with Piromelatine

100 Patents (Medical) associated with Piromelatine

Literatures (Medical) associated with Piromelatine

01 Oct 2022·Cellular and molecular neurobiologyQ3 · MEDICINE

Chronic Piromelatine Treatment Alleviates Anxiety, Depressive Responses and Abnormal Hypothalamic–Pituitary–Adrenal Axis Activity in Prenatally Stressed Male and Female Rats

Q3 · MEDICINE

Article

Author: Ivanova, Natasha ; Tchekalarova, Jana ; Laudon, Moshe ; Nenchovska, Zlatina ; Atanasova, Milena ; Mitreva, Rumyana

The prenatal stress (PNS) model in rodents can induce different abnormal responses that replicate the pathophysiology of depression. We applied this model to evaluate the efficacy of piromelatine (Pir), a novel melatonin analog developed for the treatment of insomnia, in male and female offspring. Adult PNS rats from both sexes showed comparable disturbance associated with high levels of anxiety and depressive responses. Both males and females with PNS demonstrated impaired feedback inhibition of the hypothalamic-pituitary-adrenal (HPA) axis compared to the intact offspring and increased glucocorticoid receptors in the hippocampus. However, opposite to female offspring, the male PNS rats showed an increased expression of mineralocorticoid receptors in the hippocampus. Piromelatine (20 mg/kg, i.p., for 21 days injected from postnatal day 60) attenuated the high anxiety level tested in the open field, elevated plus-maze and light-dark test, and depressive-like behavior in the sucrose preference and the forced swimming tests in a sex-specific manner. The drug reversed to control level stress-induced increase of plasma corticosterone 120 min later in both sexes. Piromelatine also corrected to control level the PNS-induced alterations of corticosteroid receptors only in male offspring. Our findings suggest that the piromelatine treatment exerts beneficial effects on impaired behavioral responses and dysregulated HPA axis in both sexes, while it corrects the PNS-induced changes in the hippocampal corticosteroid receptors only in male offspring.

01 Feb 2022·Behavioural brain researchQ3 · PSYCHOLOGY

Antidepressant actions of melatonin and melatonin receptor agonist: Focus on pathophysiology and treatment

Q3 · PSYCHOLOGY

Review

Author: Jiang, Ya-Jie ; Liu, Jian ; Zhao, Hong-Qing ; Wang, Ye-Qing ; Zou, Man-Shu ; Wang, Yu-Hong

Depression has become one of the most commonly prevalent neuropsychiatric disorders, and the main characteristics of depression are sleep disorders and melatonin secretion disorders caused by circadian rhythm disorders. Abnormal endogenous melatonin alterations can contribute to the occurrence and development of depression. However, molecular mechanisms underlying this abnormality remain ambiguous. The present review summarizes the mechanisms underlying the antidepressant effects of melatonin, which is related to its functions in the regulation of the hypothalamic-pituitary-adrenal axis, inhibition of neuroinflammation, inhibition of oxidative stress, alleviation of autophagy, and upregulation of neurotrophic, promotion of neuroplasticity and upregulation of the levels of neurotransmitters, etc. Also, melatonin receptor agonists, such as agomelatine, ramelteon, piromelatine, tasimelteon, and GW117, have received considerable critical attention and are highly implicated in treating depression and comorbid disorders. This review focuses on melatonin and various melatonin receptor agonists in the pathophysiology and treatment of depression, aiming to provide further insight into the pathogenesis of depression and explore potential targets for novel agent development.

27 Jan 2021·Reviews in the neurosciencesQ3 · MEDICINE

The role of melatonin and its analogues in epilepsy

Q3 · MEDICINE

Article

Author: Vyas, Preeti ; Vohora, Divya ; Khurana, Mallika ; Khan, Sumaira

Abstract:

Extensive research has gone into proposing a promising link between melatonin administration and attenuation of epileptic activity, the majority of which suggest its propensity as an antiseizure with antioxidant and neuroprotective properties. In the past few years, a number of studies highlighting the association of the melatonergic ligands with epilepsy have also emerged. In this context, our review is based on discussing the recent studies and various mechanisms of action that the said category of drugs exhibit in the context of being therapeutically viable antiseizure drugs. Our search revealed several articles on the four major drugs i.e. melatonin, agomelatine, ramelteon and piromelatine along with other melatonergic agonists like tasimelteon and TIK-301. Our review is suggestive of antiseizure effects of both melatonin and its analogues; however, extensive research work is still required to study their implications in the treatment of persons with epilepsy. Further evaluation of melatonergic signaling pathways and mechanisms may prove to be helpful in the near future and might prove to be a significant advance in the field of epileptology.

News (Medical) associated with Piromelatine

20 Dec 2022

·www.businesswire.com

World Alzheimer's Disease Therapeutics Analysis Report 2022: 101 Active Drugs - Market Insight, Epidemiology and Pipeline Assessment by Molecule Type, Route of Administration, Pipeline Phase - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Alzheimer's Disease Therapeutics (2022 Edition) - Market Insight, Epidemiology and Pipeline Assessment (By Molecule Type, By Route of Administration, By Pipeline Phase)" report has been added to ResearchAndMarkets.com's offering. Alzheimer's disease Therapeutics Pipeline Analysis has 101 active drugs undergoing several stages of clinical trials. The Alzheimer's disease Therapeutics Pipeline is driven by an increasing gap of unmet need of effective therapeutics that can cure Alzheimer's disease. Additionally, life expectancy has increased due to various healthcare reforms in major economies such as the U.S., Japan, and China. This has resulted in a large geriatric population which is the age group most affected by the disease. Alzheimer's prevalence is rising rapidly and despite decades of research, the disease remains incurable. The majority of therapeutics target symptom reduction and slowing the progression of the disease. The Food and Drug Administration (FDA) approved aducanumab (Aduhelm) for the treatment of certain cases of Alzheimer's disease in June 2021 and this is the first drug approved for Alzheimer's disease in decades. Eisai, Biogen, Hoffmann-La Roche, AZTherapies, Cerecin, Neurotrope, AC Immune, Cassava Sciences, AB Science, Anavex Life Sciences, Athira Pharma, Denali Therapeutics Inc., and other notable companies are developing therapeutic candidates to improve the Alzheimer's Diagnosis and treatment scenario. Scope of the Report The report analyses the Alzheimer's Disease Therapeutics in Pipeline by Molecule Type (Small Molecules, Monoclonal Antibody, Vaccine, DNA/RNA Based, Natural products, Gene Therapy, Cell Therapy, Others). The report analyses the Alzheimer's disease Therapeutics by Route of Administration (Oral, Intravenous, Intramuscular, Subcutaneous, Intrathecal, Intranasal, Other). The report analyses the Alzheimer's disease Therapeutics by Pipeline Phase (Phase I, Phase I/II, Phase II, Phase II/III, Phase III, Phase IV, Preclinical). The report analyses the Pain Management Drugs Market by Availability (Over the Counter (OTC), Prescription). The Alzheimer's Disease Therapeutics Pipeline Analysis has been analysed By Region (Americas, Europe, Asia Pacific, and MEA). The Global Pain Management Drugs Market has been analysed By Region (Americas, Europe, Asia Pacific, and MEA). The key insights of the report have been presented through the leading company shares. Also, the major, trends, drivers and challenges as well as Unmet Needs of the industry has been analysed in the report. The companies analysed in the report include Eli-Lily & Co , Elsal Co., Ltd., BioVie, Johnson and Johnson, Otsuka Pharmaceutical Co., Ltd. H. Lundbeck A/S, Novartis, Cognition Therapeutics, Merck Sharp & Dohme LLC, Biogen. Key Target Audience Alzheimer's Disease Therapeutics Companies End Users (Hospitals and clinics) Research and Development (R&D) Organizations Government Bodies & Regulating Authorities Investment Banks and Equity Firms Key Topics Covered: 1. Introduction 1.1 Alzheimer's Disease Therapeutics Overview 1.2 Scope of Research 2. Executive Summary 2.1 Market Dashboard 2.2 Regional Insights 2.3 Market Ecosystem Factors 3. Research Methodology 3.1 Data Collection Process 3.2 Market Size Calculation-Top-to-Bottom 4. Macro Economic Indicator Outlook 4.1 Global, Region wise GDP Growth 4.2 Global Medical Spending 4.3 Current Healthcare Expenditure 4.4 Pharmaceutical Spending/capita 5. Competitive Positioning 5.1 Companies' Product Positioning 5.2 Competitive positioning 5.2.1 Eli-Lily & Co 5.2.2 Elsal Co., Ltd. 5.2.3 BioVie 5.2.4 Johnson & Johnson 5.2.5 Otsuka Pharmaceutical Co., Ltd. 5.2.6 H. Lundbeck A/S 5.2.7 Novartis 5.2.8 Cognition Therapeutics 5.2.9 Merck Sharp & Dohme LLC 5.2.10 Biogen 6. Alzheimer's disease background 6.1 AD Fact Sheet 6.2 Epidemiology 6.3 Causes and Risk Factors 6.4 Diagnosis and Assessment 6.5 Unmet Needs 7. Therapeutics in Pipeline 7.1 Pipeline Scenario 7.2 Alzheimer's Therapeutics Comparative Review 8. Pipeline Analysis 9. Phase I therapeutics Overview 9.1 LY3372993 9.1.1 Drug Description 9.1.2 Outcomes 9.2 Lu AF87908 9.3 anle138b 9.4 ASN51 9.5 CMS121 9.6 IBC-Ab002 9.7 LX1001 9.8 MK-2214 9.9 MK-8189 9.10 ACU193 9.11 NIO752 9.12 ALN-APP 9.13 TB006 9.14 SNK01 9.15 Pepinemab 9.16 GB-5001 9.17 AC-1202 9.18 SHR-1707 9.19 BEY2153 9.20 JNJ-40346527 9.21 APNmAb005 9.22 NPT 2042 9.23 ALZ-101 10. Phase I/II therapeutics Overview 10.1 Posiphen 10.1.1 Drug Description 10.1.2 Outcomes 10.1.3 Collaborators 10.2 PrimeProT/ PrimeMSKT 10.3 TB006 10.4 RO7126209 10.5 DNL593 10.6 BIIB080 10.7 E2814 10.8 Tdap 10.9 ACI-35.030/ JACI-35.054 10.10 ACI-24.060 10.11 IVL3003 11. Phase II therapeutics Overview 11.1 Lecanemab 11.1.1 Drug Description 11.1.2 Outcomes 11.1.3 Collaborators 11.2 Lomecel-B 11.3 AL002 11.4 AL001 11.5 CT1812 (Elaya) 11.6 APH-1105 11.7 ATH-1017 11.8 T-817MA 11.9 Montelukast buccal film 11.10 ABBV-916 11.11 Bepranemab 11.12 TB006 11.13 LY3372689 11.14 MW150 11.15 EX039 11.16 JNJ-42847922 11.17 REM0046127 11.18 Bryostatin 1 11.19 NanoLithium NP03 11.20 AstroStem 11.21 Gantenerumab 11.22 Semorinemab 11.23 Obicetrapib 11.24 ALZ-801 11.25 CY6463 11.26 Crenezumab 11.27 T3D-959 11.28 PMZ-1620 11.29 GV1001 11.30 ACZ885 11.31 PQ912 11.32 APH-1105 11.33 SLS-005 11.34 Flos gossypii flavonoids 11.35 Human Mesenchymal Stem cells (MSCs) 11.36 JNJ-63733657 11.37 IGC-AD1 11.38 TW001 11.39 ABvac40 12. Phase II/III therapeutics Overview 12.1 Tricaprilin 12.1.1 Drug Description 12.1.2 Outcomes 12.2 ANAVEX2-73 12.3 Piromelatine 12.4 AGB101 13. Phase III therapeutics Overview 13.1 Simufilam 13.1.1 Drug Description 13.1.2 Outcomes 13.1.3 Collaborators 13.2 ATH-1017 13.3 Lecanemab 13.4 Nilotinib BE 13.5 Brexpiprazole 13.6 Masitinib 13.7 Remternetug 13.8 Donanemab 13.9 NE3107 13.10 Gantenerumab 13.11 GV-971 13.12 Aducanumab 13.13 TRx0237 13.14 Semagludtide 13.15 BPDO-1603 13.16 AR1001 13.17 KarXT 13.18 AXS-05 14. Phase IV therapeutics Overview 14.1 Choline Alfoscerate 14.1.1 Drug Description 14.1.2 Outcomes 14.2 Ebicomb 14.3 Rivastigmine 14.4 GV-971 15. Preclinical Phase therapeutics Overview 15.1 PMN310 15.1.1 Drug Description 15.1.2 Outcomes 15.1.3 Collaborators 15.2 PRX123 16. Pipeline analysis, By molecule type 16.1 Alzheimer's Therapeutics Comparative Review, by Molecule type 17. Pipeline analysis, By Route of Administration 17.1 Alzheimer's Therapeutics Comparative Review, By Route of Administration For more information about this report visit https://www.researchandmarkets.com/r/wcw7f7

Drug ApprovalPhase 2Phase 1

100 Deals associated with Piromelatine

External Link

KEGG	Wiki	ATC	Drug Bank
-	Piromelatine	-	DB12288

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 3	US	Neurim Pharmaceuticals Ltd.	12 May 2022
Alzheimer Disease	Phase 3	CA	Neurim Pharmaceuticals Ltd.	12 May 2022
Sleep Initiation and Maintenance Disorders	Phase 1	FR	Neurim Pharmaceuticals Ltd.	01 Apr 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01489969 (CTgov)	Phase 2	Sleep Initiation and Maintenance Disorders	137	Neu-P11	wahnbzhsip(mpkqgcuqfl) = nyhykjqfnx uhigjgpirp (cthbtbmpnl, wkmzhifvly - siwqdrqbhz) View more	-	06 Jun 2018

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