Circadin (melatonin prolonged release) / Lundbeck, Neurim, Flynn Pharma, Insud Pharma, Biocodex, Kuhnil Pharma, Teva - LARVOL DELTA

Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission (clinicaltrials.gov) - P4 | N=90 | Recruiting | Sponsor: Mahidol University

New P4 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

The Basel BOMP-AID Randomized Trial (clinicaltrials.gov) - P4 | N=190 | Recruiting | Sponsor: University Hospital, Basel, Switzerland | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial primary completion date • CNS Disorders

CHAMM / OP113523.PIL: Etude de bioquivalence entre Circadin et Melatonin PILEJE LP 2 mg (clinicaltrialsregister.eu) - P1 | N=24 | Not yet recruiting | Sponsor: Pileje

New P1 trial • CNS Disorders • Insomnia • Sleep Disorder

Identification of New Cyclocircadins from Cyclocybe erebia and Their Effects on the Circadian Rhythm of Human Osteosarcoma Cells. (PubMed, J Nat Prod) - "Cyclocircadins A, C, D, and F-H delayed the phase of the circadian rhythm, and reduced the amplitude of bioluminescence oscillations. In addition, cyclocircadins A, C, F, and G tended to lengthen the circadian period, whereas cyclocircadin E tended to shorten it. Cyclocircadins A and F-H were more active at lower concentrations than cyclocircadins C-E, indicating that structural variations in the seven-membered ring are critical for their activity."

Journal • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • PER2

Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) - P2 | N=68 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Dec 2025 ➔ Dec 2028

Trial completion date • CNS Disorders • Hematological Malignancies • Oncology • Sleep Disorder • Solid Tumor

Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery (clinicaltrials.gov) - P=N/A | N=120 | Recruiting | Sponsor: Al-Azhar University | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Psychiatry

Mela-Nia: A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia:n Pharmacokinetic Study (clinicaltrials.gov) - P1 | N=5 | Recruiting | Sponsor: Woolcock Institute of Medical Research | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Insomnia • Sleep Disorder

Mela-Nia: A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Woolcock Institute of Medical Research | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Insomnia • Sleep Disorder

Downregulation of circadian gene expression in patients with inflammatory bowel disease and its association with the severity of inflammation (IDDF 2025) - "The ISI scores were higher in IBD patients who completed the questionnaire compared to HCs (P= 0.03). Participants with an ISI score greater than 7 (indicating insomnia issues) exhibited lower expression levels of the CLOCK gene compared to others (P = 0.04) (IDDF2025-ABS-0040 figure 1).Download figure Open in new tab Download powerpoint Abstract IDDF2025-ABS-0040 Figure 1 Comparison of circadin gene mRNA expression levels between inflammatory bowel disease (IBD), ulcerative colitis(UC), crohn's disease (CD) patients and healthy controls (HCs)Conclusions The downregulation of circadian clock genes may constitute the molecular basis for sleep disturbances and the exacerbation of inflammation in IBD patients."

Clinical • CNS Disorders • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Insomnia • Sleep Disorder • Ulcerative Colitis • ARNTL • BMAL1 • CLOCK • CRP • CRY1 • PER1 • PER2 • PER3

TXA-MELA: Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma (clinicaltrials.gov) - P4 | N=75 | Active, not recruiting | Sponsor: Thammasat University

New P4 trial • Dermatology • Dermatopathology

Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients (clinicaltrials.gov) - P2/3 | N=70 | Not yet recruiting | Sponsor: Tanta University

Intubation • New P2/3 trial

The revival of the mini-tablets: Recent advancements, classifications and expectations for the future. (PubMed, Eur J Pharm Biopharm) - "Most recently, two novel products with different concepts were authorized by the EMA and entered the market which are highlighted in this review: the first orodispersible mini-tablet with enalapril maleate for congenital heart failure (Aqumeldi® from Proveca Pharma) and the first single unit mini-tablet with matrix-type controlled melatonin release for insomnia (Slenyto® from Neurim Pharmaceuticals)...Film-coatings enabling gastric resistance, taste masking or sustained-release properties have been realized in both fluid-bed and drum coaters using the same polymers as for conventional tablets. There is still a significant lack in regulatory guidance despite the recent success of the mini-tablet concept, starting from suitable characterization methods in the pharmacopoeias up to the design and conduct of clinical studies on mini-tablets."

Journal • Review • Cardiovascular • CNS Disorders • Congestive Heart Failure • Heart Failure • Insomnia • Sleep Disorder

Mela-Nia: A Novel Inhaled Formulation of Melatonin to Treat Adults with Insomnia: Pharmacokinetic Study (clinicaltrials.gov) - P1 | N=5 | Not yet recruiting | Sponsor: Woolcock Institute of Medical Research

New P1 trial • CNS Disorders • Insomnia • Sleep Disorder

Mela-Nia: A Novel Inhaled Formulation of Melatonin to Treat Adults with Insomnia: Efficacy Study (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Woolcock Institute of Medical Research

New P1 trial • CNS Disorders • Insomnia • Sleep Disorder • Aβ42 • BDNF • CRP • GFAP • IL6 • NEFL

The Basel BOMP-AID Randomized Trial (clinicaltrials.gov) - P4 | N=190 | Recruiting | Sponsor: University Hospital, Basel, Switzerland | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • CNS Disorders

Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery (clinicaltrials.gov) - P=N/A | N=120 | Recruiting | Sponsor: Al-Azhar University | Not yet recruiting ➔ Recruiting

Enrollment open • Surgery • Psychiatry

Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery (clinicaltrials.gov) - P=N/A | N=120 | Not yet recruiting | Sponsor: Al-Azhar University

New trial • Surgery • Psychiatry

Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) - P2 | N=68 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jun 2028 ➔ Dec 2025 | Trial primary completion date: Jun 2028 ➔ Dec 2025

Trial completion date • Trial primary completion date • CNS Disorders • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Sleep Disorder • Solid Tumor

In vitro Modified Release Studies on Melatoninergic Fluorinated Phenylalkylamides: Circumventing their Lipophilicity for Oral Administration. (PubMed, Curr Pharm Des) - "Moreover, a number of these derivatives were proven suitable for dealing with sleep onset problems, whilst others for dealing with combined sleep onset/sleep maintenance dysfunctions."

Journal • Preclinical • Sleep Disorder

Melatonin in Obese Patients in Laparoscopic Cholecystectomy (clinicaltrials.gov) - P=N/A | N=60 | Not yet recruiting | Sponsor: Ain Shams University

New trial • Anesthesia • Obesity • Pain

Melatonin treatment has consistent but transient beneficial effects on sleep measures and pain in patients with severe chronic pain: the DREAM-CP randomised controlled trial. (PubMed, Br J Anaesth) - "Circadin™ treatment did not improve sleep disturbance in patients with severe chronic pain compared with placebo at 6 weeks, but there were consistent improvements in aspects of sleep in the shorter term. Given its favourable safety profile, it could be beneficial for some patients with chronic pain."

Journal • CNS Disorders • Fibromyalgia • Musculoskeletal Pain • Oncology • Pain • Rheumatology • Sleep Disorder

Identification of Cyclocybe erebia metabolites that affect the circadian rhythm of Eluc expression under control of Bmal1 promoter in mouse fibroblast cells. (PubMed, J Biosci Bioeng) - "Compounds 1 and 2 were named cyclocircadins A and B, respectively. These findings suggested that natural diterpenoids could be a source of compounds with the activity affecting circadian rhythms."

Journal • Preclinical • CNS Disorders • Metabolic Disorders • Sleep Disorder • ARNTL

Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (clinicaltrials.gov) - P2 | N=68 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jun 2023 ➔ Jun 2028 | Trial primary completion date: Jun 2023 ➔ Jun 2028

Trial completion date • Trial primary completion date • CNS Disorders • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Sleep Disorder • Solid Tumor

Potent Lipophilic Melatoninergic x-fluoro-y-methoxy Substituted Phenylalkylamides: Molecular Dynamics Calculations and in vitro Modified Release in Aqueous Media from Tablet Formulations. (PubMed, Curr Pharm Des) - "Apart from the nature and relevant content of the formulants used, this bimodal release profile of the new analogues depends, to a large extent, on the diverse structural arrangement of their side chains in space, as nicely demonstrated by the molecular dynamics calculations, conducted in the context of this study."

Journal • Preclinical • Sleep Disorder

Correction EQL Pharma enters into license agreement with large pharmaceutical company in Turkey for Mellozzan (melatonin) [Google translation] (Cisionwire) - "EQL has entered into an exclusive license agreement for its product Mellozzan (melatonin) with a major pharmaceutical company for sales in Turkey and Kazakhstan. 'EQL has previously signed license agreements with parties for a number of countries, but this is a milestone as it is our first agreement with the sale of one of our products outside the borders of Europe,' says Axel Schörling, CEO at EQL Pharma."

Licensing / partnership • CNS Disorders