Linsitinib (OSI-906) has been evaluated in numerous clinical trials ranging from early to late phases across various indications, including non-small cell lung cancer, Ewing sarcoma, advanced solid tumors, multiple myeloma, gastrointestinal stromal tumors, and thyroid eye disease. Sponsored by pharmaceutical entities such as Astellas Pharma and Sling Therapeutics as well as academic organizations like the National Cancer Institute and EORTC, these studies encompass completed, recruiting, terminated, and withdrawn recruitment statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07753603 | RECRUITING | Thyroid Eye Disease, TED; Graves Orbitopathy |
Sling Therapeutics, Inc. |
2026-08-04 | PHASE3 |
| NCT06112340 | RECRUITING | Thyroid Eye Disease; Graves Orbitopathy; Endocrine System Diseases; Eye Diseases; Thyroid Associated Ophthalmopathy; Graves Ophthalmopathy; Thyroid Diseases; Orbital Diseases; Proptosis; IGF1R; Exophthalmos; Hashimoto |
Sling Therapeutics, Inc. |
2023-10-11 | PHASE2; PHASE3 |
| NCT05276063 | COMPLETED | Thyroid Eye Disease; Graves Orbitopathy; Endocrine System Diseases; Eye Diseases; Thyroid Associated Ophthalmopathy; Graves Ophthalmopathy; Thyroid Diseases; Orbital Diseases; Proptosis; IGF1R; Exophthalmos; Hashimoto |
Sling Therapeutics, Inc. |
2022-07-01 | PHASE2; PHASE3 |
| NCT01672736 | TERMINATED | Multiple Myeloma |
University Health Network, Toronto |
2012-09 | PHASE1; PHASE2 |
| NCT02057380 | COMPLETED | Advanced Solid Tumors |
Astellas Pharma Global Development, Inc. |
2014-04-16 | PHASE2 |
| NCT02546544 | COMPLETED | Relapsed Ewing Sarcoma; Refractory Ewing Sarcoma |
University of Oxford |
2014-03 | PHASE2 |
| NCT01427205 | WITHDRAWN | Head and Neck Cancer |
M.D. Anderson Cancer Center |
2013-06 | PHASE2 |
| NCT01560260 | COMPLETED | Carney Complex; Chondrosarcoma; Gastrointestinal Stromal Tumor; Paraganglioma |
National Cancer Institute (NCI) |
2012-03 | PHASE2 |
| NCT01533181 | COMPLETED | Recurrent Small Cell Lung Carcinoma |
National Cancer Institute (NCI) |
2012-02 | PHASE2 |
| NCT00889382 | COMPLETED | Ovarian Cancer; Solid Tumors |
Astellas Pharma Inc |
2009-08-05 | PHASE1; PHASE2 |
| NCT02546544 | Completed | Relapsed Ewing Sarcoma|Refractory Ewing Sarcoma |
University of Oxford|European Organisation for Research and Treatment of Cancer - EORTC|European Commission|Astellas Pharma Inc|Oxford University Hospitals NHS Trust |
2014-03 | Phase 2 |
| NCT01567384 | WITHDRAWN | Cancer; Neoplasms; Tumors |
Emory University |
2012-05 | PHASE1 |
| NCT01465815 | WITHDRAWN | Recurrent Skin Cancer; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Squamous Cell Carcinoma of the Skin; Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity |
OHSU Knight Cancer Institute |
2011-12 | PHASE1; PHASE2 |
| NCT01186861 | COMPLETED | Non-Small Cell Lung Cancer (NSCLC) With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy |
Astellas Pharma Inc |
2011-03-04 | PHASE2 |
| NCT01154335 | COMPLETED | Metastatic Colorectal Cancer |
SCRI Development Innovations, LLC |
2010-07 | PHASE1 |
| NCT01016860 | TERMINATED | Colorectal Cancer |
University of Colorado, Denver |
2009-12 | PHASE1 |
| NCT01221077 | COMPLETED | NSCLC; Non Small Cell Lung Cancer |
Astellas Pharma Inc |
2011-04-08 | PHASE2 |
| NCT01529684 | COMPLETED | Advanced Solid Tumors; Pharmacokinetics of 14C-OSI-906 |
Astellas Pharma Global Development, Inc. |
2012-03-19 | PHASE1 |
| NCT01533246 | COMPLETED | Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer |
National Cancer Institute (NCI) |
2012-02 | PHASE2 |
| NCT01672736 | Terminated | Multiple Myeloma |
University Health Network Toronto|Multiple Myeloma Research Consortium|Astellas Pharma Inc |
2012-09 | Phase 1|Phase 2 |
| NCT00924989 | COMPLETED | Adrenocortical Carcinoma |
Astellas Pharma Inc |
2009-12-01 | PHASE3 |
| NCT00514007 | COMPLETED | Advanced Solid Tumors |
Astellas Pharma Inc |
2007-06-18 | PHASE1 |
| NCT00739453 | COMPLETED | Advanced Solid Tumors |
Astellas Pharma Inc |
2008-10-23 | PHASE1 |
| NCT01529684 | Completed | Advanced Solid Tumors|Pharmacokinetics of 14C-OSI-906 |
Astellas Pharma Global Development Inc.|Astellas Pharma Inc |
2012-03-19 | Phase 1 |
| NCT01101906 | TERMINATED | Advanced Hepatocellular Carcinoma (HCC) |
Astellas Pharma Inc |
2011-01-10 | PHASE2 |
| NCT01334710 | TERMINATED | Liver Cancer |
Emory University |
2011-03 | PHASE2 |
| NCT01205685 | TERMINATED | Hormone-sensitive Metastatic Breast Cancer |
Vanderbilt-Ingram Cancer Center |
2010-05 | PHASE2 |
| NCT01221077 | Completed | NSCLC|Non Small Cell Lung Cancer |
Astellas Pharma Inc |
2011-04-08 | Phase 2 |
| NCT00514306 | COMPLETED | Advanced Solid Tumors |
Astellas Pharma Inc |
2007-07-05 | PHASE1 |
| NCT01013506 | WITHDRAWN | Breast Cancer |
Vanderbilt-Ingram Cancer Center |
2009-08 | PHASE2 |
| NCT01600807 | WITHDRAWN | Pancreatic Cancer, Metastatic |
Dana-Farber Cancer Institute |
PHASE1; PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-08-11)
Check the
Linsitinib (OSI-906)
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>).
- Linsitinib (OSI-906) Mechanism of Action: IGF-1R Inhibition in Orbital Fibroblast Research
- Linsitinib (OSI-906): Selectivity & Specificity
- Linsitinib (OSI-906) Working Concentration | Cell Culture | Treatment
- Linsitinib (OSI-906) Solubility in DMSO
- Linsitinib (OSI-906) Stock Solution
- Linsitinib (OSI-906) Storage
- Linsitinib (OSI-906) Stability
- Linsitinib (OSI-906) Combination Database
- Linsitinib (OSI-906) Molecular Weight
- Linsitinib (OSI-906) SMILES
- Linsitinib (OSI-906) CAS Number
- Linsitinib (OSI-906) Chemical Structure (2D and 3D)
- Linsitinib (OSI-906) IC50 for Cell-based and Cell-free Assays
- Linsitinib (OSI-906) Sigma (AMBH2D6FB336)? Try a better option.
- Linsitinib (OSI-906) MedChemExpress (HY-10191)? Try a better option.
- Linsitinib (OSI-906) Cayman (17708)? Try a better option.
- Linsitinib (OSI-906) Abcam (ab273391)? Try a better option.
- Linsitinib (OSI-906) APExBIO (A8334)? Try a better option.
- Linsitinib (OSI-906) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.