Colivelin Clinical Trials

Size	Price	Qty
1mg	USD 290
5mg	USD 870

Clinical Trials

Several clinical trials are currently evaluating interventions for neurodegenerative disorders, including neuronal ceroid lipofuscinoses and CLN3-related conditions, alongside hematologic malignancies such as acute myeloid leukemia, myelodysplastic syndrome, and non-Hodgkin lymphoma. Supported by biopharmaceutical companies and NIH institutes, these investigations encompass Phase 1, Phase 3, and non-applicable study designs. Across this portfolio, recruitment statuses range from not yet recruiting and active to completed or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04637282	Not yet recruiting	Juvenile Neuronal Ceroid Lipofuscinosis	Polaryx Therapeutics Inc.	2024-12-01	Phase 3
NCT05879744	Active not recruiting	NHL\|NHL Relapsed Adult	Cullinan Therapeutics Inc.	2023-05-31	Phase 1
NCT05143996	Recruiting	Relapsed/Refractory Acute Myeloid Leukemia (AML)\|Myelodysplastic Syndrome (MDS)	Cullinan Therapeutics Inc.	2021-11-18	Phase 1
NCT04974307	Completed	CLN3-related Disorders\|Low Vision	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)\|National Institutes of Health Clinical Center (CC)	2021-09-30	Not Applicable
NCT04480476	Withdrawn	Late-infantile Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)	REGENXBIO Inc.	2021-03-31	--
NCT04462692	Withdrawn	Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)	REGENXBIO Inc.	2021-03-31	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Colivelin functions as a brain-penetrant peptide activator of signal transducer and activator of transcription 3, driving downstream gene expression programs that suppress cell apoptosis and inhibit amyloid-beta deposition. By preserving synaptic plasticity and protecting neural cells against degenerative damage, this activation mechanism provides therapeutic relevance for clinical conditions including neuronal ceroid lipofuscinosis and hematologic malignancies.

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>).