Numerous clinical trials evaluate Cenicriviroc across conditions including HIV-1 infection, AIDS dementia complex, COVID-19, septic shock, and end-stage renal disease. Spanning Phase 1 through Phase 3 as well as Phase Not Applicable protocols, these studies are sponsored by both academic medical institutions and private organizations. Overall recruitment statuses include completed, recruiting, active not recruiting, not yet recruiting, terminated, and withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04488081 | ACTIVE_NOT_RECRUITING | COVID-19 |
QuantumLeap Healthcare Collaborative |
2020-07-31 | PHASE2 |
| NCT04334915 | WITHDRAWN | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
2022-11-22 | PHASE2 |
| NCT06329310 | Not yet recruiting | End Stage Renal Disease |
Xeltis |
2024-07 | Not Applicable |
| NCT05630885 | COMPLETED | HIV-1-infection; Elevated Cardiovascular Risk |
National Institute of Allergy and Infectious Diseases (NIAID) |
2023-05-30 | PHASE2 |
| NCT06190717 | Recruiting | Diabetes|End Stage Renal Disease |
Sonavex Inc. |
2024-02-21 | Not Applicable |
| NCT06310174 | Recruiting | Central Venous Catheter Exit Site Infection |
Johns Hopkins University |
2023-12-22 | -- |
| NCT06121115 | Completed | Septic Shock|Hypotension and Shock |
Region Skane |
2023-10-03 | -- |
| NCT05896735 | Recruiting | Multiple Trauma/Injuries |
Second Affiliated Hospital School of Medicine Zhejiang University |
2023-04-25 | -- |
| NCT05751395 | Not yet recruiting | Central Venous Catheter |
Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin |
2023-03-01 | -- |
| NCT04593940 | COMPLETED | Covid19 |
Daniel Benjamin |
2020-10-15 | PHASE3 |
| NCT04500418 | TERMINATED | Covid19 |
Charite University, Berlin, Germany |
2020-08-25 | PHASE2 |
| NCT03028740 | TERMINATED | Nonalcoholic Steatohepatitis |
Tobira Therapeutics, Inc. |
2017-04-05 | PHASE3 |
| NCT03059446 | TERMINATED | Nonalcoholic Steatohepatitis; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease |
Tobira Therapeutics, Inc. |
2017-02-14 | PHASE2 |
| NCT03517540 | COMPLETED | Non-alcoholic Steatohepatitis (NASH) |
Novartis Pharmaceuticals |
2018-09-11 | PHASE2 |
| NCT03376841 | COMPLETED | Hepatic Impairment |
Allergan |
2017-06-06 | PHASE1 |
| NCT02653625 | COMPLETED | Primary Sclerosing Cholangitis |
Tobira Therapeutics, Inc. |
2016-03-14 | PHASE2 |
| NCT02330549 | COMPLETED | Prediabetic State; Non-alcoholic Fatty Liver Disease; Type 2 Diabetes Mellitus |
Tobira Therapeutics, Inc. |
2015-07-17 | PHASE2 |
| NCT02217475 | COMPLETED | Nonalcoholic Steatohepatitis |
Tobira Therapeutics, Inc. |
2014-09-18 | PHASE2 |
| NCT02128828 | COMPLETED | AIDS Dementia Complex; HIV-1-Associated Cognitive Motor Complex; Human Immunodeficiency Virus |
University of Hawaii |
2014-04 | PHASE2 |
| NCT02684799 | COMPLETED | Healthy |
Tobira Therapeutics, Inc. |
2016-01-31 | PHASE1 |
| NCT02685462 | COMPLETED | Healthy |
Tobira Therapeutics, Inc. |
2016-01-31 | PHASE1 |
| NCT02342067 | COMPLETED | Healthy |
Tobira Therapeutics, Inc. |
2014-12 | PHASE1 |
| NCT02120547 | COMPLETED | Liver Insufficiency |
Tobira Therapeutics, Inc. |
2014-03 | PHASE1 |
| NCT01827540 | COMPLETED | HIV-infection/AIDS |
Tobira Therapeutics, Inc. |
2013-03 | PHASE1 |
| NCT01338883 | COMPLETED | HIV-1 Infection |
Tobira Therapeutics, Inc. |
2011-06 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-03-16)
Check the
Cenicriviroc
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.