Linsitinib

Overview

An orally bioavailable small molecule inhibitor of the insulin-like growth factor 1 receptor (IGF-1R) with potential antineoplastic activity. IGF-1R inhibitor OSI-906 selectively inhibits IGF-1R, which may result in the inhibition of tumor cell proliferation and the induction of tumor cell apoptosis.

Background

Indication

Investigated for use/treatment in cancer/tumors (unspecified) and solid tumors.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)	2023/11/01	NCT06112340	Phase 2	Recruiting	Sling Therapeutics, Inc.
A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)	2022/03/11	NCT05276063	Phase 2	Active, not recruiting	Sling Therapeutics, Inc.
Eurosarc Trial of Linsitinib in Advanced Ewing Sarcoma	2015/09/11	NCT02546544	Phase 2	Completed	University of Oxford
A Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial	2014/02/07	NCT02057380	Phase 2	Completed	Astellas Pharma Global Development, Inc.
Linsitinib in Treating Patients With Gastrointestinal Stromal Tumors	2012/03/22	NCT01560260	Phase 2	Completed	National Cancer Institute (NCI)
Linsitinib or Topotecan Hydrochloride in Treating Patients With Relapsed Small Cell Lung Cancer	2012/02/15	NCT01533181	Phase 2	Completed	National Cancer Institute (NCI)
Linsitinib in Treating Patients With Asymptomatic or Mildly Symptomatic Metastatic Prostate Cancer	2012/02/15	NCT01533246	Phase 2	Completed	National Cancer Institute (NCI)
A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the Body	2012/02/09	NCT01529684	Phase 1	Completed	Astellas Pharma Global Development, Inc.
Phase I/II Study of Postoperative Adjuvant Chemoradiation for Advanced-Stage Cutaneous Squamous Cell Carcinoma of the Head and Neck (cSCCHN)	2011/11/06	NCT01465815	Phase 1	Withdrawn	OHSU Knight Cancer Institute
Phase II Study of Cetuximab With or Without OSI-906 in Head and Neck Squamous Cell Carcinoma (HNSCC)	2011/09/01	NCT01427205	Phase 2	Withdrawn	M.D. Anderson Cancer Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

TEPEZZA Sales Surge as Thyroid Eye Disease Treatment Market Expands to $2.3 Billion

5 months ago

• TEPEZZA, the first FDA-approved treatment for thyroid eye disease, generated $1.9 billion in sales for 2024, with $460 million in Q4 alone, addressing a critical unmet need for patients with limited treatment alternatives. • The global thyroid eye disease market reached $2.3 billion in 2023 across seven major markets, with continued growth expected through 2034 due to increasing disease awareness and rising prevalence. • Several competitors are developing alternative therapies, including Immunovant's batoclimab and Sling Therapeutics' oral small molecule linsitinib, potentially reshaping the treatment landscape in the coming years.

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