Clinical Trials

Multiple clinical trials evaluate RITA-associated interventions across oncology and hematology indications—including multiple myeloma, acute myeloid leukemia, and non-small cell lung cancer—as well as non-oncological conditions such as ST-elevation myocardial infarction, severe asthma, and hypercholesterolemia. Spanning Phase 1, Phase 2, and Phase 4 stages alongside protocols without phase designations, recruitment statuses range from actively recruiting to completed. These studies are sponsored by a mix of academic institutions, university hospitals such as Assistance Publique - Hôpitaux de Paris, and industry partners like Advice Pharma Group srl.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05211401 RECRUITING
ST Elevated Myocardial Infarction
Assistance Publique - Hôpitaux de Paris
2022-06-01 PHASE2
NCT05260203 COMPLETED
Multiple Myeloma; Solitary Plasmacytoma; Amyloidosis; Chronic Myeloid Leukemia; Chronic Lymphocytic Leukemia; T Cell Non-Hodgkin Lymphoma; Lymphocytic Lymphoma; Hodgkin Lymphoma; B-cell Non Hodgkin Lymphoma; Acute Myeloid Leukemia; Myelodysplasia; Chronic Myeloproliferative Disorder; Treatment Adherence; Treatment Adherence and Compliance
Advice Pharma Group srl
2022-06-04
NCT05153551 COMPLETED
Autism Spectrum Disorder
University of Michigan
2022-01-27
NCT05260203 Completed
Multiple Myeloma|Solitary Plasmacytoma|Amyloidosis|Chronic Myeloid Leukemia|Chronic Lymphocytic Leukemia|T Cell Non-Hodgkin Lymphoma|Lymphocytic Lymphoma|Hodgkin Lymphoma|B-cell Non Hodgkin Lymphoma|Acute Myeloid Leukemia|Myelodysplasia|Chronic Myeloproliferative Disorder|Treatment Adherence|Treatment Adherence and Compliance
Advice Pharma Group srl
2022-06-04 Not Applicable
NCT05153551 Completed
Autism Spectrum Disorder
University of Michigan|Blue Cross Blue Shield of Michigan Foundation
2022-01-27 Not Applicable
NCT03806127 Completed
Irritable Bowel Syndrome
Urovant Sciences GmbH
2018-12-31 Phase 2
NCT00571987 COMPLETED
Cancer of the Breast
University of Arkansas
2004-09 PHASE1; PHASE2
NCT01051986 COMPLETED
Coronary Artery Disease
Seoul National University Hospital
2008-09
NCT01524601 COMPLETED
Disorder Related to Renal Transplantation; Hypercholesterolemia
University of Oslo School of Pharmacy
2012-02 PHASE4
NCT00779025 Completed
Coitus
Johnson & Johnson Consumer and Personal Products Worldwide
2008-01 Not Applicable
NCT00690703 COMPLETED
Non Small Cell Lung Cancer; Pulmonary Metastases
Angiodynamics, Inc.
2001-07 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-12)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

RITA directly binds to p53, thereby blocking its interaction with MDM2 and preventing MDM2-mediated p53 ubiquitination and degradation. The resulting stabilization of p53 activates downstream JNK signaling and induces apoptosis, suppressing tumor cell growth in oncological settings including multiple myeloma, acute myeloid leukemia, and non-small cell lung cancer evaluated in clinical research.

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>).

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