Cyproheptadine hydrochloride sesquihydrate Clinical Trials

Size	Price	Qty
100mg	USD 147
500mg	USD 347

Clinical Trials

Cyproheptadine hydrochloride sesquihydrate has been evaluated in numerous clinical trials spanning Early Phase 1 through Phase 4 for indications including alcohol use disorder, COVID-19 pneumonia, pediatric feeding disorders, nausea, and muscle spasticity. Sponsored by both industry entities and academic research centers, these studies assess outcomes ranging from pharmacokinetic profiles and therapeutic efficacy to pediatric eating habits. Across the trial portfolio, recruitment statuses encompass completed, active, recruiting, terminated, and unknown states.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04488081	ACTIVE_NOT_RECRUITING	COVID-19	QuantumLeap Healthcare Collaborative	2020-07-31	PHASE2
NCT05469165	RECRUITING	Ischemic Mitral Regurgitation	Laval University	2023-06-20	PHASE2
NCT06751290	COMPLETED	Pediatric Feeding Disorder, Chronic; Avoidant Restrictive Food Intake Disorder	University of Miami	2024-12-30	PHASE4
NCT06175273	COMPLETED	Pediatric Cancer; Nutrition Related Cancer; Nutrition Aspect of Cancer; Muscle Loss; Malnutrition, Child	Corey Hawes	2024-01-31	PHASE2; PHASE3
NCT07006181	COMPLETED	Appetite Loss	Indonesia University	2024-11-04
NCT06147622	COMPLETED	Alcohol Use Disorder	Kinnov Therapeutics	2024-04-23	PHASE1
NCT05087381	COMPLETED	Treatment Efficacy	Chulalongkorn University	2021-10-01	PHASE4
NCT04979221	UNKNOWN	COVID-19 Pneumonia	Hospital de Clinicas de Porto Alegre	2021-07-26	PHASE3
NCT04876573	UNKNOWN	Viral Pneumonia; COVID-19 Pneumonia; Serotonin Syndrome; Platelet Dysfunction	Ciusss de L'Est de l'Île de Montréal	2021-06-01	PHASE2
NCT04820751	UNKNOWN	Viral Pneumonia; Serotonin Syndrome; Platelet Dysfunction	Ciusss de L'Est de l'Île de Montréal	2021-04-10	PHASE3
NCT04108104	COMPLETED	Alcohol Use Disorder	Kinnov Therapeutics	2019-11-30	PHASE2
NCT03593811	COMPLETED	Nausea	Vanderbilt University Medical Center	2018-08-03	EARLY_PHASE1
NCT02418949	COMPLETED	Stroke; Muscle Spasticity; Hemiparesis	Shirley Ryan AbilityLab	2015-11
NCT02568007	TERMINATED	Feeding Behaviors	Medical College of Wisconsin	2015-12	PHASE4
NCT01538693	COMPLETED	Spinal Cord Injury	T. George Hornby	2011-12
NCT01688570	COMPLETED	Stroke	Medical College of Wisconsin	2011-08	EARLY_PHASE1
NCT01940978	COMPLETED	ADHD; Attention Deficit Hyperactivity Disorder; Attention Deficit Disorder With Hyperactivity; Mental Disorders Diagnosed in Childhood; Attention Deficit and Disruptive Behavior Disorders	Douglas Sears	2014-03	PHASE4
NCT01132547	TERMINATED	Cancer	University of South Florida	2010-06	PHASE3
NCT01675050	TERMINATED	Functional Abdominal Pain	University of Michigan	2012-08	PHASE2
NCT00949117	TERMINATED	Leukemia; Lymphoma; Malnutrition; Myelodysplastic Syndromes; Unspecified Childhood Solid Tumor, Protocol Specific; Weight Changes	University of South Florida	2009-09	PHASE2
NCT01314989	UNKNOWN	Failure to Thrive	St. Justine's Hospital	2010-12	PHASE4
NCT01076283	COMPLETED	Alcoholism	Brown University	2009-12	PHASE2
NCT00066248	COMPLETED	Brain Tumor; Central Nervous System Tumors; Cachexia; Leukemia; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases; Unspecified Childhood Solid Tumor, Protocol Specific	University of South Florida	2003-06	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-03-16)

Check the Cyproheptadine hydrochloride sesquihydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cyproheptadine hydrochloride sesquihydrate acts as a potent non-selective 5-HT2 receptor antagonist with an IC50 of 0.6 nM and an inhibitor of the histone methyltransferase SETD7/9, thereby blocking downstream serotonergic signaling cascades and epigenetic chromatin modifications to modulate cellular signaling and neuroendocrine pathways. This inhibition attenuates serotonin-mediated smooth muscle contraction and central appetite suppression, providing the mechanistic basis for its clinical investigation in pediatric feeding disorders, nausea, alcohol use disorder, and muscle spasticity.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).