Clinical Trials

Numerous clinical trials evaluate conditions such as diabetic neuropathies, dermatosis papulosa nigra, diabetic retinopathy, and acute necrotizing pancreatitis across Phase 1 through Phase 4 and non-applicable phase classifications. Conducted by academic, biotechnology, and pharmaceutical sponsors, these studies encompass diverse recruitment statuses ranging from active recruitment and completion to withdrawal and termination.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07209514 ENROLLING_BY_INVITATION
Diabetic Peripheral Neuropathic Pain (DPN)
TriCity Research Center
 2025-09-16
NCT04443595 UNKNOWN
Pancreatitis; Pancreatitis, Acute Necrotizing; Pancreatic Diseases
First People's Hospital of Hangzhou
 2020-07-01
NCT06361108 RECRUITING
Diabetic Peripheral Neuropathic Pain
Zhejiang Hanmai Pharmaceutical Technology Co., Ltd.
 2024-05-16 PHASE1
NCT06287736 Not yet recruiting
Diabetic Peripheral Neuropathy
Ohio State University|Neuright Inc.
 2024-03-01 Not Applicable
NCT06099080 Active not recruiting
Dermatosis Papulosa Nigra
DermBiont Inc.
 2023-11-07 Phase 2
NCT04766450 UNKNOWN
Diabetic Neuropathies
Ain Shams University
 2021-12-01 PHASE4
NCT05159856 Recruiting
Diabetes Complications|type1diabetes|Children Only|Diabetic Neuropathies|Arterial Stiffness
Steno Diabetes Center Copenhagen|Steno Diabetes Center Sjaelland
 2022-05-03 --
NCT05041816 Withdrawn
Diabetic Peripheral Neuropathy
University of Oklahoma
 2021-09-01 Not Applicable
NCT04873232 Recruiting
Diabetic Peripheral Neuropathy
Helixmith Co. Ltd.
 2021-05-17 Phase 3
NCT02332005 COMPLETED
Diabetic Peripheral Neuropathy
NeuromaxBionevia
 2014-11 PHASE2; PHASE3
NCT01041859 COMPLETED
Diabetic Peripheral Neuropathy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2009-12 PHASE3
NCT00726713 COMPLETED
Type 2 Diabetic Peripheral Neuropathy (DPN)
Pamlab, Inc.
 2008-06 PHASE4
NCT01063868 TERMINATED
Diabetic Neuropathy, Painful; Diabetic Polyneuropathy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2010-01 PHASE3
NCT00643760 COMPLETED
Neuropathy, Diabetic
XenoPort, Inc.
 2008-03 PHASE2
NCT00933998 COMPLETED
Diabetic Peripheral Neuropathy
Carolina Musculoskeletal Institute
 2006-06
NCT00476151 COMPLETED
Diabetic Peripheral Neuropathy; Neuralgia
EpiCept Corporation
 2007-07 PHASE2
NCT00348894 TERMINATED
Pain
Pfizer
 2006-07 PHASE2
NCT00156078 COMPLETED
Diabetic Neuropathy, Painful
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2005-01 PHASE4

(data from https://clinicaltrials.gov, updated on 2025-10-15)

Check the Diarylpropionitrile (DPN) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Diarylpropionitrile (DPN) selectively binds to and activates estrogen receptor β (ERβ) with an EC50 of 0.85 nM, driving downstream transcriptional signaling and neuroprotective gene regulation. This receptor activation enhances neuronal cell survival and suppresses neuroinflammatory cascades, offering therapeutic relevance for neuroprotection in conditions such as diabetic peripheral neuropathy and neuropathic pain.

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.