Prednisolone Acetate Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 3 and non-interventional stages are evaluating contexts relevant to prednisolone acetate, with recruitment statuses currently listed as recruiting or not yet recruiting. Sponsored by organizations including ReAlta Life Sciences Inc., SingHealth Polyclinics, Spark Therapeutics Inc., and Eli Lilly and Company, these studies target diverse conditions such as steroid-refractory graft-versus-host disease, acute and chronic asthma, hemophilia A, and atopic dermatitis. Together, these efforts demonstrate the broad investigation of corticosteroid-related therapeutic regimens across severe inflammatory, autoimmune, and respiratory disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06343792	Not yet recruiting	Steroid Refractory GVHD	ReAlta Life Sciences Inc.	2024-05	Phase 2
NCT06377345	Not yet recruiting	Asthma\|Asthma Attack\|Asthma in Children\|Asthma Acute\|Asthma Chronic	SingHealth Polyclinics	2024-04-20	Not Applicable
NCT06297486	Recruiting	Hemophilia A	Spark Therapeutics Inc.	2024-03-13	Phase 3
NCT06119529	Recruiting	Healthy\|Atopic Dermatitis	Eli Lilly and Company	2023-11-01	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Prednisolone acetate binds to intracellular glucocorticoid receptors, inducing receptor translocation to the nucleus to modulate gene transcription and suppress pro-inflammatory cytokine signal transduction. This targeted gene regulation inhibits leukocyte activation and inflammatory mediator production, which provides the pharmacological basis for suppressing hyper-inflammatory responses in clinical conditions such as asthma, graft-versus-host disease, and inflammatory dermatoses.

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>).