Cabazitaxel has been evaluated across numerous Phase I through Phase IV clinical trials targeting prostate cancer—including progressive metastatic castration-resistant and hormone-sensitive subtypes—as well as glioblastoma multiforme and adrenocortical carcinoma. These studies evaluate the compound as monotherapy and in combination regimens for refractory advanced malignancies, with recruitment statuses ranging from active and completed to terminated, withdrawn, or unknown. Trial sponsors include university medical centers and healthcare trusts alongside major pharmaceutical organizations such as AstraZeneca and Janssen Research & Development.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06632977 | RECRUITING | Castration-Resistant Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8 |
Alliance for Clinical Trials in Oncology |
2025-02-06 | PHASE2 |
| NCT07213674 | RECRUITING | Metastatic Castration-resistant Prostate Cancer |
Amgen |
2025-11-28 | PHASE3 |
| NCT06470243 | RECRUITING | Castration-Resistant Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8 |
SWOG Cancer Research Network |
2024-11-27 | PHASE3 |
| NCT07611110 | RECRUITING | Metastatic Castration-resistant Prostate Cancer |
AstraZeneca |
2026-05-04 | PHASE3 |
| NCT06353386 | RECRUITING | Prostatic Neoplasms, Castration-Resistant |
Merck Sharp & Dohme LLC |
2024-05-20 | PHASE1; PHASE2 |
| NCT06691984 | ACTIVE_NOT_RECRUITING | Metastatic Castration-resistant Prostate Cancer |
Amgen |
2024-12-09 | PHASE3 |
| NCT02703623 | ACTIVE_NOT_RECRUITING | Castration Levels of Testosterone; Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; PSA Progression; Stage IV Prostate Adenocarcinoma AJCC v7 |
M.D. Anderson Cancer Center |
2016-05-18 | PHASE2 |
| NCT04337580 | RECRUITING | Prostate Cancer; Refractory Cancer; Castration Resistant Prostatic Cancer |
Wake Forest University Health Sciences |
2021-03-05 | PHASE2 |
| NCT04592237 | ACTIVE_NOT_RECRUITING | Aggressive Variant Prostate Carcinoma; Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Metastatic Prostate Neuroendocrine Carcinoma; Metastatic Prostate Small Cell Carcinoma; Stage IV Prostate Cancer AJCC v8 |
M.D. Anderson Cancer Center |
2020-12-29 | PHASE2 |
| NCT06085729 | RECRUITING | Prostate Cancer |
M.D. Anderson Cancer Center |
2024-02-29 | PHASE1; PHASE2 |
| NCT05818683 | RECRUITING | Metastatic Castration-resistant Prostate Neoplasms; Metastatic Hormone-sensitive Prostate Cancer |
Janssen Research & Development, LLC |
2023-04-26 | PHASE1 |
| NCT05762536 | RECRUITING | Metastatic Castration-resistant Prostate Cancer |
Erasmus Medical Center |
2023-11-29 | PHASE2 |
| NCT03903835 | RECRUITING | Metastatic Castration-resistant Prostate Cancer (mCRPC); Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) |
Karolinska Institutet |
2019-02-01 | PHASE3 |
| NCT03258320 | RECRUITING | Prostate Cancer Patients |
Shanghai Jiao Tong University School of Medicine |
2015-01 | PHASE2; PHASE3 |
| NCT06738303 | RECRUITING | Metastatic Prostate Cancer; Metastatic Castration-resistant Prostate Cancer |
Case Comprehensive Cancer Center |
2025-07-14 | PHASE2 |
| NCT06890832 | NOT_YET_RECRUITING | Metastatic Castration-resistant Prostate Cancer, MCRPC |
Jina Pharmaceuticals Inc. |
2025-05 | PHASE2 |
| NCT05563558 | RECRUITING | Prostate Cancer Metastatic |
Fundacion Oncosur |
2023-05-05 | PHASE2 |
| NCT05340374 | ACTIVE_NOT_RECRUITING | Metastatic Castration-resistant Prostate Cancer; mCRPC |
Peter MacCallum Cancer Centre, Australia |
2022-07-14 | PHASE1; PHASE2 |
| NCT03263650 | COMPLETED | Prostate Cancer Aggressiveness; Prostate Carcinoma |
M.D. Anderson Cancer Center |
2017-10-03 | PHASE2 |
| NCT02202772 | ACTIVE_NOT_RECRUITING | Urothelial Carcinoma of the Urinary Bladder |
Guarionex J. Decastro |
2014-12-01 | PHASE1; PHASE2 |
| NCT04709276 | ACTIVE_NOT_RECRUITING | Metastatic Prostate Neuroendocrine Carcinoma; Metastatic Prostate Cancer |
Andrew J. Armstrong, MD |
2021-06-07 | PHASE2 |
| NCT01952223 | ACTIVE_NOT_RECRUITING | Adenocarcinoma of Prostate; Progression of Prostate Cancer |
UNICANCER |
2013-12 | PHASE3 |
| NCT04622761 | UNKNOWN | Prostate Cancer |
The Clatterbridge Cancer Centre NHS Foundation Trust |
2021-01-15 | PHASE2 |
| NCT05005728 | COMPLETED | Metastatic Castration-Resistant Prostate Cancer |
Xencor, Inc. |
2021-10-22 | PHASE2 |
| NCT03764540 | TERMINATED | Metastatic Prostate Cancer |
Centre hospitalier de l'Université de Montréal (CHUM) |
2019-04-01 | PHASE2 |
| NCT03419234 | ACTIVE_NOT_RECRUITING | Castration Levels of Testosterone; Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma in the Soft Tissue; Prostate Carcinoma Metastatic in the Bone; Stage IV Prostate Adenocarcinoma AJCC v7 |
ECOG-ACRIN Cancer Research Group |
2018-04-26 | PHASE2 |
| NCT02218606 | COMPLETED | Prostate Cancer |
Memorial Sloan Kettering Cancer Center |
2014-08 | PHASE2 |
| NCT03934840 | COMPLETED | Prostate Cancer |
Masonic Cancer Center, University of Minnesota |
2019-10-10 | PHASE2 |
| NCT02478502 | TERMINATED | Testicular Cancer |
University Hospital, Akershus |
2015-06 | PHASE2 |
| NCT02115165 | COMPLETED | Non-seminomatous Germ-cell Tumors |
Gustave Roussy, Cancer Campus, Grand Paris |
2014-07-23 | PHASE2 |
| NCT02985957 | COMPLETED | Prostate Cancer |
Bristol-Myers Squibb |
2017-03-26 | PHASE2 |
| NCT03050866 | UNKNOWN | Circulating Tumor Cell; Metastatic Prostate Cancer |
Erasmus Medical Center |
2017-02-21 | PHASE2 |
| NCT03101046 | COMPLETED | Prostate Carcinoma; Castration-resistant Prostate Cancer; Circulating Tumor Cells; Chemotherapy |
UNICANCER |
2018-11-15 | PHASE2 |
| NCT02961257 | COMPLETED | Prostate Cancer Metastatic |
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie |
2017-05-05 | PHASE3 |
| NCT02903160 | COMPLETED | Prostate Cancer |
Icahn School of Medicine at Mount Sinai |
2017-01-13 | PHASE2 |
| NCT04495179 | COMPLETED | Progressive Metastatic Castrate-Resistant Prostate Cancer |
AstraZeneca |
2020-08-04 | PHASE2 |
| NCT02543255 | COMPLETED | Prostate Cancer |
University Health Network, Toronto |
2016-09 | PHASE2 |
| NCT03356912 | UNKNOWN | Prostate Cancer; Castration-resistant Prostate Cancer |
Consorzio Oncotech |
2017-11-22 | PHASE2 |
| NCT03048942 | COMPLETED | HER2 Negative Metastatic Breast Cancer |
University Hospitals Bristol and Weston NHS Foundation Trust |
2014-12-18 | PHASE2 |
| NCT03257891 | UNKNOWN | Adrenocortical Carcinoma |
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia |
2018-01-25 | PHASE2 |
| NCT04622761 | Not yet recruiting | Prostate Cancer |
The Clatterbridge Cancer Centre NHS Foundation Trust|University of Liverpool |
2021-01-15 | Phase 2 |
| NCT03295565 | COMPLETED | Prostate Cancer Metastatic; Metastasis |
The Netherlands Cancer Institute |
2017-05-07 | PHASE2; PHASE3 |
| NCT03878524 | TERMINATED | Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Anatomic Stage IV Breast Cancer AJCC v8; Anemia; Ann Arbor Stage III Hodgkin Lymphoma; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Castration-Resistant Prostate Carcinoma; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphoid System Neoplasm; Locally Advanced Pancreatic Adenocarcinoma; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Primary Myelofibrosis; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Hematologic Malignancy; Recurrent Hodgkin Lymphoma; Recurrent Myelodysplastic Syndrome; Recurrent Myelodysplastic/Myeloproliferative Neoplasm; Recurrent Myeloproliferative Neoplasm; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Recurrent Small Lymphocytic Lymphoma; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Chronic Lymphocytic Leukemia; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Chronic Myelomonocytic Leukemia; Refractory Hematologic Malignancy; Refractory Hodgkin Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Myelodysplastic Syndrome; Refractory Myelodysplastic/Myeloproliferative Neoplasm; Refractory Non-Hodgkin Lymphoma; Refractory Plasma Cell Myeloma; Refractory Primary Myelofibrosis; Refractory Small Lymphocytic Lymphoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma |
OHSU Knight Cancer Institute |
2020-04-01 | PHASE1 |
| NCT01913652 | COMPLETED | Dedifferentiated Liposarcoma |
European Organisation for Research and Treatment of Cancer - EORTC |
2014-10 | PHASE2 |
| NCT04495179 | Completed | Progressive Metastatic Castrate-Resistant Prostate Cancer |
AstraZeneca|Parexel |
2020-08-04 | Phase 2 |
| NCT02254785 | UNKNOWN | Metastatic Castration-Resistant Prostatic Cancer |
British Columbia Cancer Agency |
2014-10 | PHASE2 |
| NCT03392428 | COMPLETED | Cancer of the Prostate; Metastatic Cancer |
Australian and New Zealand Urogenital and Prostate Cancer Trials Group |
2018-01-29 | PHASE2 |
| NCT03110588 | WITHDRAWN | Metastatic Prostate Cancer |
University of Alabama at Birmingham |
2018-05-09 | PHASE1 |
| NCT01505868 | COMPLETED | Castration Levels of Testosterone; Castration-Resistant Prostate Carcinoma; Lymphadenopathy; Metastatic Prostate Carcinoma; Prostate Adenocarcinoma; Prostate Carcinoma Metastatic in the Bone; Prostate Small Cell Carcinoma |
M.D. Anderson Cancer Center |
2012-07-11 | PHASE1; PHASE2 |
| NCT02512458 | COMPLETED | Bone Metastatic Prostate Cancer |
Hellenic Cooperative Oncology Group |
2015-10-29 | PHASE2 |
| NCT02522715 | ACTIVE_NOT_RECRUITING | Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer AJCC v7 |
OHSU Knight Cancer Institute |
2015-08-13 | PHASE1; PHASE2 |
| NCT03043989 | TERMINATED | Prostate Cancer |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2017-03-21 | PHASE1 |
| NCT02844582 | TERMINATED | Hormone-Resistant Prostate Cancer; Stage IV Prostate Adenocarcinoma |
University of California, Davis |
2017-12-20 | PHASE2 |
| NCT02485691 | COMPLETED | Prostate Cancer Metastatic |
Sanofi |
2015-11-09 | PHASE4 |
| NCT02621190 | WITHDRAWN | Prostatic Neoplasms |
Erasmus Medical Center |
2016-02 | PHASE2 |
| NCT02560337 | COMPLETED | Ovarian Cancer |
Vejle Hospital |
2015-09 | PHASE2 |
| NCT01978873 | UNKNOWN | Prostate Cancer |
Örebro University, Sweden |
2012-11 | PHASE3 |
| NCT02379390 | TERMINATED | Prostate Cancer Metastatic |
Sanofi |
2015-06-17 | PHASE2 |
| NCT03257891 | Unknown status | Adrenocortical Carcinoma |
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia|San Luigi Gonzaga Hospital |
2018-01-25 | Phase 2 |
| NCT01956149 | COMPLETED | Gastric Cancer |
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
2013-09 | PHASE2 |
| NCT01616875 | COMPLETED | Infiltrating Bladder Urothelial Carcinoma |
University Hospitals Bristol and Weston NHS Foundation Trust |
2012-07-25 | PHASE2 |
| NCT01668459 | COMPLETED | Transitional Cell Carcinoma |
Dr Anjali Zarkar |
2013-01 | PHASE2; PHASE3 |
| NCT01693549 | COMPLETED | Breast Cancer |
Hellenic Cooperative Oncology Group |
2012-09 | PHASE2 |
| NCT02044354 | COMPLETED | Metastatic Castration-resistant Prostate Cancer |
Gustave Roussy, Cancer Campus, Grand Paris |
2014-05-22 | PHASE3 |
| NCT02166658 | TERMINATED | Breast Cancer; Lung Cancer; Recurrent Brain Metastases; Progressive Brain Metastases |
AIO-Studien-gGmbH |
2015-08 | PHASE2 |
| NCT01740570 | WITHDRAWN | Brain Cancer |
M.D. Anderson Cancer Center |
2013-04 | PHASE1; PHASE2 |
| NCT03043989 | Terminated | Prostate Cancer |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|Maryland Technology Development Corporation |
2017-03-21 | Phase 1 |
| NCT01845792 | TERMINATED | Prostate Cancer |
University of Colorado, Denver |
2013-07 | PHASE2 |
| NCT01866449 | COMPLETED | Glioblastoma Multiforme (GBM) WHO Grade IV |
University of Ulm |
2013-10 | PHASE2 |
| NCT01174368 | COMPLETED | Prostate Cancer |
The Rogosin Institute |
2010-06 | PHASE2 |
| NCT03114254 | COMPLETED | Penile Neoplasm |
University Hospitals Bristol and Weston NHS Foundation Trust |
2014-12-05 | PHASE2 |
| NCT01830231 | UNKNOWN | Urothelium Transitional Cell Carcinoma |
Associació per a la Recerca Oncologica, Spain |
2012-10 | PHASE2; PHASE3 |
| NCT01594918 | COMPLETED | Metastatic Castration-resistant Prostate Cancer |
Rahul Aggarwal |
2012-06 | PHASE1 |
| NCT01578655 | COMPLETED | Prostate Cancer |
Achieve Life Sciences |
2012-08 | PHASE3 |
| NCT01757171 | COMPLETED | Gastric Adenocarcinoma; Gastroesophageal Adenocarcinoma; Distal Esophageal Adenocarcinoma |
Weill Medical College of Cornell University |
2012-12 | PHASE2 |
| NCT01518283 | COMPLETED | Hormone Refractory Prostate Cancer |
Spanish Oncology Genito-Urinary Group |
2012-05 | PHASE2 |
| NCT01913067 | WITHDRAWN | Brain Metastasis; Breast Cancer; Non Small Cell Lung Cancer |
Jules Bordet Institute |
2013-09 | PHASE2 |
| NCT02074137 | COMPLETED | Prostate Cancer Metastatic |
Sanofi |
2014-07 | PHASE4 |
| NCT01934894 | TERMINATED | Metastatic Breast Cancer With Intracranial Metastases |
SCRI Development Innovations, LLC |
2014-05 | PHASE2 |
| NCT02441894 | COMPLETED | Prostate Cancer |
Sanofi |
2015-04 | PHASE4 |
| NCT01941550 | TERMINATED | High-Risk Cancer |
RWTH Aachen University |
2013-07 | PHASE2 |
| NCT01541007 | COMPLETED | Metastatic Castration Resistant Prostate Cancer |
Jeffrey Yachnin M.D., PhD. |
2012-04 | PHASE2 |
| NCT01308567 | COMPLETED | Prostate Cancer |
Sanofi |
2011-05-05 | PHASE3 |
| NCT01718353 | COMPLETED | Prostate Cancer Metastatic |
Sanofi |
2013-03 | PHASE2 |
| NCT01308580 | COMPLETED | Prostate Cancer |
Sanofi |
2011-04 | PHASE3 |
| NCT01779479 | COMPLETED | Primary Breast Cancer |
GBG Forschungs GmbH |
2013-02 | PHASE2 |
| NCT01420250 | COMPLETED | Prostate Cancer |
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University |
2011-09-22 | PHASE1 |
| NCT01751308 | COMPLETED | Malignant Solid Tumor - Malignant Nervous System Neoplasm |
Sanofi |
2013-02 | PHASE1; PHASE2 |
| NCT01513733 | COMPLETED | Prostate Cancer |
Andrew J. Armstrong, MD |
2012-01 | PHASE1 |
| NCT02035124 | WITHDRAWN | Advanced Prostate Cancer |
SCRI Development Innovations, LLC |
2014-04 | PHASE2 |
| NCT01600339 | COMPLETED | Urothelial Carcinoma |
Rambam Health Care Campus |
2012-05 | PHASE2 |
| NCT01379339 | COMPLETED | Squamous Cell Carcinoma of the Head and Neck |
Krzysztof Misiukiewicz |
2011-04 | PHASE1 |
| NCT01254279 | COMPLETED | Prostate Cancer Metastatic |
Sanofi |
2010-12 | PHASE3 |
| NCT01558219 | COMPLETED | Metastatic Prostate Cancer |
Tampere University Hospital |
2011-11 | PHASE2 |
| NCT01528163 | COMPLETED | Squamous Cell Carcinoma of the Head and Neck |
Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
2012-02 | PHASE2 |
| NCT01324583 | COMPLETED | Prostate Cancer |
Sanofi |
2011-01 | PHASE1 |
| NCT01469338 | TERMINATED | Diarrhea; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer |
University of Southern California |
2012-07 | PHASE2 |
| NCT01438307 | COMPLETED | Non-small Cell Lung Cancer (NSCLC); Stage IV NSCLC; Metastatic NSCLC |
University of Alabama at Birmingham |
2011-09 | PHASE2 |
| NCT01437488 | COMPLETED | Urothelial Carcinoma |
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University |
2012-02-16 | PHASE2 |
| NCT01650285 | TERMINATED | Prostate Cancer |
Brown University |
2013-01 | PHASE2 |
| NCT01747239 | TERMINATED | Ovarian Cancer |
Vejle Hospital |
2013-01 | PHASE2 |
| NCT01140607 | COMPLETED | Neoplasm Malignant |
Sanofi |
2010-05 | PHASE1 |
| NCT01511536 | COMPLETED | Prostate Cancer |
Sanofi |
2012-03 | PHASE1; PHASE2 |
| NCT01500720 | COMPLETED | Small Cell Lung Cancer |
Sanofi |
2012-03 | PHASE2 |
| NCT01649635 | COMPLETED | Prostate Cancer |
Sanofi |
2012-07 | PHASE4 |
| NCT01576029 | COMPLETED | Prostatic Neoplasms |
Sanofi |
2012-08 | PHASE2 |
| NCT01447225 | COMPLETED | Solid Tumors |
Merrimack Pharmaceuticals |
2011-10 | PHASE1 |
| NCT01527929 | COMPLETED | Neoplasm Malignant |
Sanofi |
2012-04 | PHASE1 |
| NCT01750866 | WITHDRAWN | Castrate-resistant Metastatic Prostate Cancer |
Case Comprehensive Cancer Center |
2013-02 | PHASE2 |
| NCT01531205 | TERMINATED | Prostate Cancer |
H. Lee Moffitt Cancer Center and Research Institute |
2012-05 | PHASE2 |
| NCT02204332 | TERMINATED | Colorectal Cancer |
Hospital Clinico Universitario de Santiago |
2013-03 | PHASE2 |
| NCT01981668 | WITHDRAWN | Prostatic Neoplasms |
Nova Scotia Cancer Centre |
PHASE1 | |
| NCT01852578 | COMPLETED | NSCLC |
Hellenic Oncology Research Group |
2012-09 | PHASE2 |
| NCT01620242 | COMPLETED | Recurrent Head and Neck Cancer; Metastatic Head and Neck Cancer |
UNICANCER |
2012-04 | PHASE2 |
| NCT01497964 | COMPLETED | Gastric Cancer |
Sanofi |
2011-12 | PHASE1; PHASE2 |
| NCT01335204 | TERMINATED | Prostate Cancer; Prostatic Neoplasms |
Medical University of South Carolina |
2011-06 | PHASE1; PHASE2 |
| NCT01083615 | TERMINATED | Castrate-Resistant Prostate Cancer; Hormone Refractory Prostate Cancer |
Achieve Life Sciences |
2010-03 | PHASE3 |
| NCT00925743 | COMPLETED | Solid Cancer |
Sanofi |
2009-06 | PHASE1 |
| NCT01365130 | TERMINATED | Esophageal; Gastrooesophageal Cancer; Gastric Cancer |
howard safran |
2011-06 | PHASE2 |
| NCT01001221 | TERMINATED | Neoplasms, Malignant |
Sanofi |
2009-11 | PHASE1; PHASE2 |
| NCT01087021 | COMPLETED | Neoplasms, Malignant |
Sanofi |
2010-03 | PHASE1 |
| NCT00417079 | COMPLETED | Neoplasms; Prostatic Neoplasms |
Sanofi |
2007-01 | PHASE3 |
| NCT01755390 | COMPLETED | Advanced Solid Tumor |
Sanofi |
1999-10 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-09-02)
Check the
Cabazitaxel
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.