Succinic anhydride Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

Several clinical trials are currently evaluating interventions across diverse conditions, including ventilator-associated pneumonia, metastatic breast cancer, cardiopulmonary arrest with pediatric acute lymphoblastic leukemia during resuscitation, and prostate cancer. Spanning Phase 1, Phase 2, and non-interventional designs, these upcoming studies are presently listed as not yet recruiting. The protocols are sponsored by pharmaceutical and biotechnology organizations such as Technophage SA, ABSCINT NV/SA, and Debiopharm International SA, alongside research entities including the Pediatric Clinical Research Platform and University Hospital Geneva.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06370598	Not yet recruiting	Pneumonia Ventilator-Associated	Technophage SA\|VectorB2B	2024-09	Phase 1\|Phase 2
NCT06369831	Not yet recruiting	Metastatic Breast Cancer	ABSCINT NV/SA	2024-08	Phase 2
NCT04464603	Not yet recruiting	Cardiopulmonary Arrest\|Pediatric ALL\|Resuscitation	Pediatric Clinical Research Platform\|University Hospital Geneva	2024-06-01	Not Applicable
NCT06395753	Not yet recruiting	Prostate Cancer	Debiopharm International SA	2024-06	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Succinic anhydride acts as a cyclic anhydride reagent that covalently acylates free amine or hydroxyl groups on targeting polypeptides, enabling the formation of stable, noncleavable linkers within antibody-drug conjugates. By securely anchoring therapeutic payloads to cell-targeting moieties, this chemical conjugation prevents premature drug release in circulation and facilitates selective cytotoxic targeting, which is relevant to oncological applications such as metastatic breast cancer and prostate cancer.

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>).