Clinical Trials

Multiple clinical trials investigate the therapeutic applications of Cytochalasin D across distinct indications, including infertility as well as bleeding and platelet refractoriness in hematological patients undergoing intensive chemotherapy. Sponsored by academic and medical institutions such as the Centre Hospitalier Universitaire de Saint Etienne, the Institut de Cancérologie de la Loire, and Ibn Sina Hospital, these Phase II protocols range in recruitment status from active to completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05091684 Recruiting
Hematological Patients|Bleeding|Platelet Refractoriness
Centre Hospitalier Universitaire de Saint Etienne|Institut de Cancérologie de la Loire
 2022-02-10 Phase 2
NCT03677492 COMPLETED
Infertility
Ibn Sina Hospital
 2018-09-25

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cytochalasin D selectively binds to actin filaments to inhibit actin polymerization, thereby disrupting intracellular actin dynamics and inducing the phosphorylation and cytoplasmic retention of Yap. This inhibition of cytoskeletal reorganization impairs cellular motility and structural integrity, providing a mechanistic basis for its clinical evaluation in reproductive procedures for infertility as well as in hematological disease management.

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>).

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