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)
Mechanism and Biochemical Profile
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>).