Numerous clinical trials evaluate therapeutic applications across diverse inflammatory, autoimmune, and perioperative conditions, including ulcerative colitis, rheumatoid arthritis, systemic lupus erythematosus, spondyloarthropathy, ocular inflammatory diseases, alopecia, and opioid-free anesthesia care. Ranging from Phase 1/2 evaluations to Phase 4 trials and observational studies, these investigations are led by industry sponsors like Pfizer alongside academic medical centers. Their recruitment statuses range from completed to actively recruiting or unknown.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05577962 | RECRUITING | Opioid-free Anesthesia |
Beijing Friendship Hospital |
2024-08-01 | PHASE4 |
| NCT07406204 | NOT_YET_RECRUITING | Alopecia Areata; Alopecia Totalis (AT); Alopecia Universalis |
Hayat Abad Medical Complex, Peshawar |
2026-02-15 | PHASE4 |
| NCT04485325 | COMPLETED | Rheumatic Arthritis |
Dr. Frank Behrens |
2019-11-04 | PHASE4 |
| NCT03755466 | UNKNOWN | Rheumatoid Arthritis |
Shinshu University |
2018-11-21 | PHASE2 |
| NCT05133297 | COMPLETED | Rheumatoid Arthritis |
Hangzhou Highlightll Pharmaceutical Co., Ltd |
2022-02-16 | PHASE2 |
| NCT05728008 | Completed | Ulcerative Colitis |
IRCCS San Raffaele |
2022-04-05 | -- |
| NCT04721808 | Completed | Arthritis Rheumatoid |
Pfizer |
2021-01-22 | -- |
| NCT03580343 | UNKNOWN | Uveitis; Scleritis |
Washington University School of Medicine |
2019-04-04 | PHASE2 |
| NCT03288324 | Completed | Cutaneous Lupus|Systemic Lupus Erythematosus |
Children''s Hospital Medical Center Cincinnati|Pfizer |
2017-08-23 | Phase 1|Phase 2 |
| NCT01741493 | COMPLETED | Rheumatoid Arthritis |
AbbVie (prior sponsor, Abbott) |
2012-11 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-08-05)
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>).