Numerous clinical trials spanning Phase 1 to Phase 4 have evaluated toremifene citrate, primarily focusing on hormone-receptor-positive breast cancer, prostatic intraepithelial neoplasia, bone fracture risk reduction, and COVID-19. Spearheaded by diverse pharmaceutical sponsors and academic institutions, these studies encompass completed, actively recruiting, terminated, and withdrawn protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05891093 | RECRUITING | Breast Cancer |
Fudan University |
2023-06-01 | PHASE3 |
| NCT05472792 | RECRUITING | Breast Cancer; Quality of Life |
UNC Lineberger Comprehensive Cancer Center |
2022-05-17 | PHASE2 |
| NCT03351062 | UNKNOWN | Breast Cancer Female |
Chinese Anti-Cancer Association |
2017-11 | PHASE3 |
| NCT06495515 | UNKNOWN | CANCER; BRAEST CANCER; Late Frontline |
Tianjin Medical University Cancer Institute and Hospital |
2024-08-01 | PHASE2 |
| NCT02132390 | UNKNOWN | Breast Cancer; Chemotherapy Induced Amenorrhea; Ovarian Function Suppression |
Peking Union Medical College Hospital |
2014-05 | PHASE3 |
| NCT02097459 | UNKNOWN | Breast Cancer |
Peking Union Medical College Hospital |
2014-03 | PHASE3 |
| NCT03238703 | WITHDRAWN | HER2/Neu Negative; Invasive Breast Carcinoma; Postmenopausal; Stage 0 Breast Cancer; Stage IA Breast Cancer |
Fred Hutchinson Cancer Center |
2018-09-01 | PHASE4 |
| NCT04531748 | WITHDRAWN | Covid19 |
Reena Mehra, MD |
2021-12 | PHASE2 |
| NCT02506790 | UNKNOWN | Breast Cancer |
N.N. Petrov National Medical Research Center of Oncology |
2015-07 | PHASE2 |
| NCT02132000 | UNKNOWN | Breast Cancer Patients in Premenopausal; Estrogen and/or Progesterone Receptor Positive |
Fengxi Su |
2014-04 | PHASE2; PHASE3 |
| NCT02089854 | UNKNOWN | Female Breast Cancer |
Peking Union Medical College Hospital |
2014-11 | PHASE4 |
| NCT02344940 | COMPLETED | Breast Cancer |
Shanghai Jiao Tong University School of Medicine |
2014-12 | PHASE4 |
| NCT00437359 | TERMINATED | Breast Neoplasms |
Japan Breast Cancer Research Network |
2007-05 | PHASE2 |
| NCT00003865 | WITHDRAWN | Ovarian Cancer |
George Washington University |
1999-07-22 | PHASE2 |
| NCT02271282 | COMPLETED | Normal Healthy Volunteers |
Mayo Clinic |
2014-12 | PHASE1 |
| NCT02353429 | UNKNOWN | Desmoid Type-fibromatosis |
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
2012-11 | PHASE2 |
| NCT01072318 | UNKNOWN | Breast Cancer |
Korean Breast Cancer Study Group |
2010-01 | PHASE4 |
| NCT01214291 | WITHDRAWN | Risk of Bone Fracture Occurrences |
GTx |
2011-03 | PHASE3 |
| NCT01214291 | Withdrawn | Risk of Bone Fracture Occurrences |
GTx|Ipsen |
2011-03 | Phase 3 |
| NCT01417754 | COMPLETED | Circulatory; Change |
Satakunta Central Hospital |
2010-09 | PHASE3 |
| NCT00002529 | COMPLETED | Breast Cancer |
ETOP IBCSG Partners Foundation |
1993-05 | PHASE3 |
| NCT00106691 | COMPLETED | Preneoplastic Conditions; Prostatic Intraepithelial Neoplasia |
GTx |
2005-01 | PHASE3 |
| NCT00534846 | COMPLETED | Breast Pain |
Satakunta Central Hospital |
2007-04 | PHASE3 |
| NCT00129142 | COMPLETED | Prostate Cancer; Osteoporosis; Fractures |
GTx |
2003-10 | PHASE3 |
| NCT00044291 | COMPLETED | Breast Neoplasms; Neoplasms, Hormone-dependent |
Intarcia Therapeutics |
2002-06 | PHASE3 |
| NCT00267553 | Terminated | Breast Neoplasms|Neoplasms Hormone-Dependent |
Intarcia Therapeutics |
2005-11 | Phase 3 |
| NCT00106691 | Completed | Preneoplastic Conditions|Prostatic Intraepithelial Neoplasia |
GTx |
2005-01 | Phase 3 |
| NCT00020735 | COMPLETED | Prostate Cancer |
Joel Nelson, MD |
2001-04 | PHASE2 |
| NCT00002595 | COMPLETED | Desmoid Tumor |
Advocate Lutheran General Hospital |
1991-07 | PHASE2 |
| NCT00010322 | TERMINATED | Breast Cancer |
Intarcia Therapeutics |
2000-10 | PHASE3 |
| NCT00267553 | TERMINATED | Breast Neoplasms; Neoplasms, Hormone-Dependent |
Intarcia Therapeutics |
2005-11 | PHASE3 |
| NCT00097344 | TERMINATED | Breast Neoplasms; Neoplasms, Hormone-Dependent |
Intarcia Therapeutics |
2004-12 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2024-02-08)
Check the
Toremifene Citrate (NK 622)
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>).
- Toremifene Citrate (NK 622) Solubility in DMSO
- Toremifene Citrate (NK 622) Stock Solution
- Toremifene Citrate (NK 622) Storage
- Toremifene Citrate (NK 622) Stability
- Toremifene Citrate (NK 622) Molecular Weight
- Toremifene Citrate (NK 622) SMILES
- Toremifene Citrate (NK 622) CAS Number
- Toremifene Citrate (NK 622) Chemical Structure (2D and 3D)
- Toremifene Citrate (NK 622) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.