Clinical Trials

Multiple clinical trials evaluate interventions across conditions such as apnea of prematurity, respiratory distress syndrome, amyotrophic lateral sclerosis, osteoarthritis, and Crohn disease. Supported by academic medical centers, hospital institutes, and commercial entities—including the University of California, Irvine, Insel Gruppe AG, and Corin—these Phase 2, Phase 4, and non-applicable phase studies demonstrate a broad research scope. The dataset encompasses varied recruitment statuses, including actively recruiting, completed post-approval, terminated, and unknown trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06327152 Recruiting
Apnea of Prematurity
University of California Irvine
2024-02-22 Phase 2
NCT02096211 COMPLETED
Non-inflammatory Degenerative Joint Disease; Osteoarthritis; Avascular Necrosis; Post-Traumatic Osteoarthritis of Hip
DePuy Orthopaedics
2014-06-01
NCT05908227 Recruiting
Respiratory Distress Syndrome
Insel Gruppe AG University Hospital Bern
2023-07-01 Not Applicable
NCT06318585 Recruiting
Amyotrophic Lateral Sclerosis|Motor Neuron Disease
Istituto Auxologico Italiano
2023-04-03 --
NCT06087666 Recruiting
Preterm
Instituto de Investigación Hospital Universitario La Paz
2023-02-01 Not Applicable
NCT05178719 COMPLETED
Osteoporosis
Polyclinic K-center
2016-03-16
NCT04370535 UNKNOWN
Crohn Disease
Ciim Plus, d.o.o.
2018-10-17
NCT03803306 COMPLETED
Essential Hypertension
NMP Medical Research Institute
2018-07-12
NCT02528318 TERMINATED
Respiratory Distress Syndrome
Windtree Therapeutics
2015-08 PHASE2
NCT04607018 COMPLETED
Effects of the Elements
General Hospital Pula
2015-11-17
NCT02074059 COMPLETED
Respiratory Distress Syndrome
Windtree Therapeutics
2014-02 PHASE2
NCT00722007 COMPLETED
Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis
Corin
2008-04-24
NCT00546598 TERMINATED
Non-inflammatory Joint Disease; Osteoarthritis; Avascular Necrosis; Congenital Hip Dysplasia; Post-traumatic Arthritis
DePuy Orthopaedics
2006-01-01 PHASE4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the PMA chemical (Phorbol 12-myristate 13-acetate) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Phorbol 12-myristate 13-acetate operates as a nanomolar activator of protein kinase C, binding to the regulatory domain to drive downstream signaling including sphingosine-1-phosphate induction. This kinase stimulation modulates cellular differentiation, inflammatory responses, and membrane excitability, which underpins research efforts evaluated in clinical trials for conditions such as Crohn disease, respiratory distress syndrome, and osteoarthritis.

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>).

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