Clinical Trials

Multiple clinical trials evaluate piperine as a bioenhancer or sensory agonist across diverse indications, including plasma curcuminoid pharmacokinetics, fibromyalgia, joint pain, acute post-stroke oropharyngeal dysphagia, prostate cancer, and myelodysplastic syndrome. Spanning Phase 1, Phase 2, and non-applicable phase classifications, these studies exhibit recruitment statuses ranging from not yet recruiting to completed. Prominent trial sponsors include academic and medical institutions such as the University of Rochester and Hospital de Mataró.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07753018 NOT_YET_RECRUITING
Fibromyalgia (FM)
Ain Shams University
 2026-08-01 PHASE2
NCT06063486 RECRUITING
Clonal Cytopenia of Undetermined Significance; Essential Thrombocythemia; Myelodysplastic Syndrome; Myelofibrosis; Polycythemia Vera
University of Southern California
 2024-03-01 PHASE2
NCT07699575 NOT_YET_RECRUITING
Joint Pains
Centre Hospitalier Universitaire de la Réunion
 2026-09-14
NCT05958173 UNKNOWN
Oropharyngeal Dysphagia; Swallowing Disorder
Hospital de Mataró
 2023-09-01
NCT06080841 RECRUITING
Locally Advanced Cervical Cancer
National Institute of Cancerología
 2023-04-19
NCT07149961 COMPLETED
ST Elevation Myocardial Infarction (STEMI); Malondialdehyde; Hs-CRP; Curcumin; Curcuma Xanthorrhiza; High-sensitivity C-reactive Protein
Universitas Diponegoro
 2025-02-05
NCT04731844 COMPLETED
Prostate Cancer; Multiple Myeloma; Smoldering Multiple Myeloma (SMM); Monoclonal Gammopathy of Undetermined Significance
University of Rochester
 2021-12-14 PHASE2
NCT05735626 UNKNOWN
Stroke; Stroke, Acute; Oropharyngeal Dysphagia; Swallowing Disorder
Hospital de Mataró
 2021-07-01
NCT05542394 Completed
Plasma Levels of Different Curcuminoids Preparations
University of Jordan|Nutritional Fundamentals for Health
 2022-09-20 Not Applicable
NCT04741620 COMPLETED
Oropharyngeal Dysphagia; Dysphagia; Swallowing Disorder
Hospital de Mataró
 2019-01-17
NCT05430087 COMPLETED
Systemic Lupus Erythematosus
Saiful Anwar Hospital
 2020-03-01 PHASE2
NCT04731844 Recruiting
Prostate Cancer|Multiple Myeloma|Smoldering Multiple Myeloma (SMM)|Monoclonal Gammopathy of Undetermined Significance
University of Rochester
 2021-12-14 Phase 2
NCT02598726 COMPLETED
Bladder Spasm; Malignant Neoplasm; Pain; Urinary Urgency
Mayo Clinic
 2016-03-01 PHASE1
NCT01893424 COMPLETED
Pain
Hadassah Medical Organization
 2013-08 PHASE1
NCT01383694 COMPLETED
Deglutition Disorders
Hospital de Mataró
 2011-06 PHASE1; PHASE2
NCT01324089 COMPLETED
Focus of the Study: Normal Volunteers
University of Wisconsin, Madison
 2011-03
NCT01331382 COMPLETED
Healthy
Northumbria University
 2010-04
NCT00181662 Completed
Healthy
Massachusetts General Hospital
 2005-08 Not Applicable

(data from https://clinicaltrials.gov, updated on 2026-08-11)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Piperine binds to transient receptor potential vanilloid 1 channels and inhibits hepatic UDP-glucuronosyltransferases, thereby suppressing phase II metabolic glucuronidation and modulating sensory neuronal activity. This mechanistic combination increases compound bioavailability and stimulates swallowing neurophysiology, providing a therapeutic rationale for clinical trials addressing oropharyngeal dysphagia and various inflammatory and hematologic disorders.

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>).

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Note: Technical data last updated: Sep 1, 2026.