Numerous clinical trials evaluate therapeutic interventions across a broad range of conditions, including kidney transplant rejection, ductal carcinoma in situ, gastroenteropancreatic neuroendocrine tumors, colorectal neoplasms, and polycystic ovarian syndrome. Spanning Phase 1 through Phase 4, these studies are sponsored by academic medical centers, university health systems, and commercial entities, including the University of Guadalajara, Assistance Publique - Hôpitaux de Paris, and Ipsen. Recruitment statuses across the portfolio vary, featuring protocols that are not yet recruiting, actively recruiting, completed, or withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06624644 | RECRUITING | Melanoma (Skin Cancer); Melanoma Stage IIIB-IV; Cutaneous Melanoma; Unresectable Melanoma |
Linnaeus Therapeutics, Inc. |
2025-08-06 | PHASE2; PHASE3 |
| NCT05749588 | RECRUITING | Triple-negative Breast Cancer |
Fudan University |
2023-03-30 | PHASE2 |
| NCT07717671 | NOT_YET_RECRUITING | Visual Impairment; Cerebral Visual Impairment; Neurodevelopmental Disorders; Prematurity |
Università degli Studi di Brescia |
2026-07-01 | |
| NCT07523269 | RECRUITING | Hypertension (HTN) |
Aktiia SA |
2026-04 | |
| NCT05584670 | RECRUITING | Solid Tumor |
Sanofi |
2022-11-29 | PHASE1; PHASE2 |
| NCT07057622 | RECRUITING | NETS Ga68 Lu177 |
HTA Co., Ltd. |
2023-12-12 | PHASE3 |
| NCT05141149 | ACTIVE_NOT_RECRUITING | Pancreatic Cancer |
Prestige Biopharma Limited |
2023-06-05 | PHASE1; PHASE2 |
| NCT04130516 | ACTIVE_NOT_RECRUITING | Solid Tumor, Adult |
Linnaeus Therapeutics, Inc. |
2019-10-21 | PHASE1; PHASE2 |
| NCT06269549 | ACTIVE_NOT_RECRUITING | Osteoarthritis, Knee |
University of Primorska |
2024-03-11 | |
| NCT07711782 | COMPLETED | Polycystic Ovarian Syndrome (PCOS); Reproductive Health |
University of Lahore |
2026-01-18 | |
| NCT07609524 | COMPLETED | Cardiac Abnormalities |
University of Lahore |
2025-06-12 | |
| NCT06912425 | COMPLETED | Kidney Diseases; Diet, Healthy; Dietary Habits; Exercise; Kidney Disease; Educational; Body Composition; Renal Failure , Chronic |
University of Guadalajara |
2024-10-01 | |
| NCT07586969 | COMPLETED | Poly Cystic Ovary Syndrome |
University of Lahore |
2024-09-11 | |
| NCT04794127 | COMPLETED | Liposarcoma, Myxoid; Liposarcoma, Dedifferentiated; Liposarcoma, Round Cell |
Mario Negri Institute for Pharmacological Research |
2022-02-02 | PHASE2 |
| NCT05324501 | TERMINATED | Recurrent Glioblastoma |
Biodexa Pharmaceuticals |
2022-10-19 | PHASE1 |
| NCT05901636 | COMPLETED | Influenza Prevention |
Janssen Vaccines & Prevention B.V. |
2023-05-17 | PHASE1; PHASE2 |
| NCT04499170 | WITHDRAWN | Balance Disorders Water |
Universidade Norte do Paraná |
2024-01 | |
| NCT06351488 | Not yet recruiting | Kidney Transplant Patients Eligible for a Solid Biopsy |
Assistance Publique - Hôpitaux de Paris|CGenetix|Institut National de la Santé Et de la Recherche Médicale France |
2024-06-10 | -- |
| NCT05752422 | UNKNOWN | ADHD |
CNS Onlus |
2023-06-15 | |
| NCT03667092 | COMPLETED | Midgut Neuroendocrine Tumors |
University Hospital, Toulouse |
2018-09-01 | |
| NCT06217458 | Not yet recruiting | DCIS|Breast Carcinoma in Situ|Calcification |
Clinical Hospital Center Rijeka |
2024-03-01 | Not Applicable |
| NCT01744249 | COMPLETED | Neuroendocrine Tumors; Advanced Cancer |
Grupo Espanol de Tumores Neuroendocrinos |
2011-11 | PHASE2; PHASE3 |
| NCT06178146 | Recruiting | IrAE |
Jun Wang|Qianfoshan Hospital |
2023-09-01 | Phase 4 |
| NCT04277221 | UNKNOWN | Glioblastoma Multiforme |
Safe Save Medical Cell Sciences & Technology Co.,Ltd. |
2019-09-19 | PHASE3 |
| NCT04424641 | TERMINATED | Locally Advanced or Metastatic Solid Tumor(s); Prostate Cancer; Esophageal Cancer; Triple Negative Breast Cancer (TNBC); Squamous Cell Carcinoma of Head and Neck (SCCHN); Non-small Cell Lung Cancer (NSCLC); Bladder Cancer; Uterine Cancer |
Genmab |
2020-07-15 | PHASE1; PHASE2 |
| NCT04748978 | UNKNOWN | Uterine Fibroid; Myoma;Uterus |
University of Cagliari |
2020-09-01 | |
| NCT04546802 | WITHDRAWN | Hepatocellular Carcinoma; Hepatoma; Liver Cell Carcinoma; Hepatitis C |
Bayside Health |
2019-09 | PHASE3 |
| NCT02969785 | COMPLETED | Athletic Injury; Low Back Pain |
Universidade Norte do Paraná |
2017-09-01 | |
| NCT02836925 | COMPLETED | Indolent B-cell Lymphoma; Hepatitis C |
Fondazione Italiana Linfomi - ETS |
2016-03 | PHASE2 |
| NCT02713763 | COMPLETED | Pancreatic Neuroendocrine Tumour Metastatic |
Grupo Espanol de Tumores Neuroendocrinos |
2017-02-14 | PHASE2 |
| NCT03747016 | UNKNOWN | Caesarean Section |
Shanghai First Maternity and Infant Hospital |
2018-12-01 | |
| NCT02895958 | TERMINATED | Hepatitis C |
Mater Misericordiae University Hospital |
2018-03-15 | PHASE4 |
| NCT00916708 | UNKNOWN | Endometrial Cancer |
Azienda Ospedaliera San Giovanni Battista |
2008-09 | |
| NCT02698371 | COMPLETED | Dental Adhesives/Restorations Performance |
University Fernando Pessoa |
2015-11 | |
| NCT03207204 | COMPLETED | Tooth Bleaching; Dentin Sensitivity |
University of Sao Paulo |
2017-07-02 | |
| NCT02983435 | COMPLETED | Low Back Pain; Osteopathic Manipulative Treatment |
Universidade Norte do Paraná |
2016-12 | |
| NCT02231762 | COMPLETED | Gastroenteropancreatic Neuroendocrine Tumors |
Ipsen |
2014-10 | PHASE2 |
| NCT02847286 | COMPLETED | HIV- Prevention |
International Partnership for Microbicides, Inc. |
2015-09-01 | PHASE1 |
| NCT02029196 | COMPLETED | Healthy Volunteers |
Imperial Brands PLC |
2013-12 | |
| NCT02813460 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2016-06 | PHASE1 |
| NCT02133690 | COMPLETED | Rotavirus Gastroenteritis |
Serum Institute of India Pvt. Ltd. |
2014-05 | PHASE3 |
| NCT01756079 | COMPLETED | Hepatitis C |
Merck Sharp & Dohme LLC |
2013-02-06 | PHASE4 |
| NCT02406976 | UNKNOWN | Morbid Obesity |
Hospital de Clinicas de Porto Alegre |
2010-08 | |
| NCT02157155 | COMPLETED | Ketoacidosis; Diabetes Mellitus Type 1 |
University of Aarhus |
2014-06 | |
| NCT01819350 | COMPLETED | Dental Biofilm pH |
Federal University of Paraíba |
2011-08 | PHASE2 |
| NCT00863239 | COMPLETED | Hepatitis C, Chronic |
Biolex Therapeutics, Inc. |
2009-03 | PHASE2 |
| NCT01061658 | UNKNOWN | Rotavirus Gastroenteritis |
Shantha Biotechnics Limited |
2010-07 | PHASE1; PHASE2 |
| NCT00757926 | WITHDRAWN | Rotavirus Infections |
Shantha Biotechnics Limited |
2009-09 | PHASE1; PHASE2 |
| NCT00505271 | COMPLETED | Breast Cancer |
Epeius Biotechnologies |
2007-07 | PHASE1; PHASE2 |
| NCT01091298 | COMPLETED | Rotavirus Gastroenteritis |
Shantha Biotechnics Limited |
2010-04 | PHASE1 |
| NCT00953589 | COMPLETED | Hepatitis C, Chronic |
Biolex Therapeutics, Inc. |
2009-07 | PHASE2 |
| NCT00820534 | COMPLETED | Cold Sore |
Novartis |
2008-12 | PHASE4 |
| NCT01920269 | COMPLETED | Bladder Cancer TNM Staging Primary Tumor (T) Ta; Bladder Cancer TNM Staging Primary Tumor (T) T1; Bladder Cancer Transitional Cell Grade |
University of Rome Tor Vergata |
1994-01 | PHASE2; PHASE3 |
| NCT00090233 | COMPLETED | Rotavirus Infections |
Merck Sharp & Dohme LLC |
2001-01 | PHASE3 |
| NCT00035919 | WITHDRAWN | Colorectal Neoplasms |
University of Southern California |
2002-11 | PHASE1; PHASE2 |
| NCT00239187 | COMPLETED | Type 2 Diabetes |
OPKO Health, Inc. |
2005-09 | PHASE1 |
| NCT00239148 | COMPLETED | Type 1 Diabetes |
OPKO Health, Inc. |
2005-06 | PHASE1 |
| NCT00743080 | COMPLETED | Uterine Myomas |
University Magna Graecia |
2008-01 | PHASE4 |
| NCT00121745 | TERMINATED | Pancreatic Cancer |
Epeius Biotechnologies |
2005-07 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-04-22)
Check the
G-1 (LNS 8801)
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.