Rolipram Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 329

Clinical Trials

Several clinical trials, predominantly Phase 1 and Phase 2 studies, have evaluated rolipram for neurological and psychiatric conditions—including major depressive disorder, Huntington disease, and multiple sclerosis—alongside evaluations in healthy volunteers. Prominently sponsored by government bodies such as the National Institute of Mental Health and corporate entities like GlaxoSmithKline, these investigations encompass varying operational statuses. While Phase 2 research in multiple sclerosis and Phase 1 PET imaging in depression were completed, other trials evaluating brain PDE4 engagement have been terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05522673	TERMINATED	Depression	National Institute of Mental Health (NIMH)	2023-02-08	PHASE1
NCT02743377	COMPLETED	Nervous System Disease	National Institute of Mental Health (NIMH)	2018-04-04	PHASE1; PHASE2
NCT00369798	COMPLETED	Major Depressive Disorder; Healthy	National Institute of Mental Health (NIMH)	2006-08-02	PHASE1
NCT01602900	COMPLETED	Huntington Disease	GlaxoSmithKline	2011-11-22	PHASE1
NCT01215552	TERMINATED	Healthy Elderly Volunteers	Dart NeuroScience, LLC	2010-09	PHASE1
NCT01215552	Terminated	Healthy Elderly Volunteers	Dart NeuroScience LLC	2010-09	Phase 1
NCT00250172	COMPLETED	Dosimetry; Healthy	National Institute of Mental Health (NIMH)	2005-10-31	PHASE1
NCT00011375	COMPLETED	Multiple Sclerosis	National Institute of Neurological Disorders and Stroke (NINDS)	2001-02	PHASE2

(data from https://clinicaltrials.gov, updated on 2024-03-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rolipram selectively binds to phosphodiesterase-4 (PDE4), specifically inhibiting PDE4B and PDE4D isoforms to prevent cyclic adenosine monophosphate (cAMP) degradation and increase intracellular cAMP levels. This elevated cAMP signaling dampens inflammatory mediator release and modulates neural signaling, providing the therapeutic basis for clinical trials in major depressive disorder, multiple sclerosis, and Huntington disease.

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>).