Clinical Trials

Numerous clinical trials evaluate the biological role and clinical utility of Substance P, spanning early phase 1 through phase 4 as well as unspecified trial phases. Supported by academic institutions, university medical centers, and government bodies such as Cairo University and the National Institute of Mental Health, these studies investigate conditions including primary dysmenorrhea, postoperative pain, head and neck cancer, asthma, chronic obstructive pulmonary disease, and panic disorder. Overall recruitment statuses across this research landscape encompass completed, recruiting, suspended, and withdrawn trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06462287 RECRUITING
Apnea, Obstructive
University Hospital, Rouen
 2024-03-05 PHASE2
NCT07585721 NOT_YET_RECRUITING
Symptomatic Apical Periodontitis
Future University in Egypt
 2026-06-01
NCT07701551 NOT_YET_RECRUITING
Symptomatic Irreversible Pulpitis (SIP)
Cairo University
 2026-08-01 PHASE4
NCT07453576 RECRUITING
Persistent Apical Periodontitis
KEZBAN MELTEM ÇOLAK
 2025-10-01
NCT06959004 RECRUITING
Migraine
Danish Headache Center
 2025-05-13
NCT06632080 NOT_YET_RECRUITING
Healthy Volunteers Only
Danish Headache Center
 2024-10-14
NCT03738878 TERMINATED
Hypertension
Vanderbilt University Medical Center
 2018-11-15 PHASE4
NCT06317064 COMPLETED
Primary Dysmenorrhea
Lahore Medical Research Center, LLP
 2024-03-15 PHASE3
NCT06106386 COMPLETED
Post Operative Pain; Inflammation
Ain Shams University
 2024-01-01
NCT03081897 SUSPENDED
Head and Neck Cancer
Charite University, Berlin, Germany
 2016-07
NCT06081335 COMPLETED
Pain, Postoperative; Irreversible Pulpitis; Apical Periodontitis
Ain Shams University
 2023-03-15
NCT03035838 WITHDRAWN
Traumatic Brain Injury
Arun Gupta
 2021-11 EARLY_PHASE1
NCT02820558 UNKNOWN
Diabetes Mellitus, Type 1
Vanilloid Genetics Inc.
 2016-05 PHASE1
NCT04594317 UNKNOWN
Postoperative Pain; Apical Periodontitis
Cairo University
 2021-02-01
NCT04676763 COMPLETED
Skin Diseases
GlaxoSmithKline
 2021-03-02
NCT04319549 UNKNOWN
Acute Irreversible Pulpitis With Apical Periodontitis
Cairo University
 2020-08-01
NCT02130687 COMPLETED
Type 2 Diabetes Mellitus; Hypertension
Vanderbilt University
 2014-06
NCT04070001 COMPLETED
Crowding, Tooth
Yeşim KAYA
 2017-08-01
NCT04103801 COMPLETED
Immunisation Anxiety Related Reaction; Pain, Acute
Jordan University of Science and Technology
 2017-07-14
NCT01280149 COMPLETED
Seasonal Allergic Rhinitis
Northwestern University
 2011-01 PHASE1
NCT02036281 COMPLETED
Terminally Ill; Histologically-confirmed Advanced Cancer; Pain, Intractable
University of Texas Southwestern Medical Center
 2014-01 PHASE1
NCT01919944 COMPLETED
Pruritus
Vanda Pharmaceuticals
 2013-08 PHASE1
NCT01854177 COMPLETED
Chronic Obstructive Pulmonary Disease
Dartmouth-Hitchcock Medical Center
 2013-07
NCT01413542 COMPLETED
Hypertension; Diabetes Type 2
Vanderbilt University
 2011-11
NCT01580423 COMPLETED
Chronic Obstructive Pulmonary Disease
Dartmouth-Hitchcock Medical Center
 2012-04
NCT01599728 COMPLETED
Heart Failure; Endothelium
University of Edinburgh
 2012-05
NCT01391598 UNKNOWN
Fibromyalgia
Federal University of São Paulo
 2010-01 PHASE3
NCT00735735 TERMINATED
Low Back Pain
Kovacs Foundation
 2009-02
NCT00977223 COMPLETED
Healthy Volunteers
University Hospital, Rouen
 2009-06 PHASE4
NCT00547612 COMPLETED
Pancreatic Cancer
National Institutes of Health Clinical Center (CC)
 2007-09 PHASE1
NCT00088738 COMPLETED
Panic Disorder; Healthy
National Institute of Mental Health (NIMH)
 2004-07-27 PHASE1
NCT00160862 COMPLETED
Healthy
Heidelberg University
 2003-05 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-11)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Substance P functions as an endogenous 11-amino-acid neuropeptide agonist that selectively binds to the neurokinin-1 receptor, initiating downstream G-protein-coupled intracellular signaling cascades. This pathway activation modulates nociceptive signal transmission, neurogenic inflammation, and autonomic stress responses, directly underlying its pathophysiological involvement in conditions such as postoperative pain, primary dysmenorrhea, asthma, and panic disorder.

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.