About IGIA Pharmaceuticals

IGIA Pharmaceuticals, Inc (IGIA), a pharmaceutical company based outside of Cincinnati, Ohio, specializing in the development of pharmaceutical products for the treatment of orphan indications or small population indications with an unmet medical need. IGIA has developed novel formulation technology that facilitates clinical studies in infants and children.

IGIA’s current focus is the development of IG-100 (dasatinib), an inhibitor of multiple signaling kinases for the treatment of Noonan syndrome-associated cardiac dysfunction in pediatric patients. IGIA obtained an exclusive world-wide license from Yale University for the novel use of dasatinib for the treatment of pediatric congenital and adult cardiac indications effective 31 March 2017.

IGIA is committed to complete the Phase 2a trial of IG-100 (dasatinib) by Q3 of 2021.

Overview of IGIA Pharmaceuticals Pipeline

IGIA Pharmaceuticals is repurposing dasatinib (IG-100), an orally bioavailable inhibitor of multiple signaling kinases, for the treatment of Noonan Syndrome (NS) and Noonan Syndrome with Multiple Lentigines (NSML) with associated cardiac dysfunction in infants. Infants presenting with hypertrophic cardiomyopathy (HCM) during the first 6 months of life have a 69% risk of dying during the first year of life. Once HCM is established, and particularly after development of Congestive Heart Failure (CHF), it may be too late for effective pharmacological intervention.
This innovative early treatment is thought to effectively treat HCM; stopping and even reversing the thickening of the heart muscle that leads to significant morbidity and mortality. Low dose dasatinib has been shown to block aberrant cell signaling that is responsible for the development of HCM.

Previous clinical experience with dasatinib in pediatric patients with an oncology indication* and strong pharmacological evidence for the prevention of cardiac failure in a mouse model of NS and NSML at doses 40 to 100-fold lower than currently used clinically in pediatric oncology patients supports clinical entry.

It is IGIA’s intention to evaluate IG-100 in a Phase 2a study, which will be the first time that low-dose dasatinib is administered to NS and NSML pediatric patients with diagnosed HCM. This study will establish initial safety and pharmacology in infants in order to identify dosing regimens for subsequent studies.


* pediatric patients aged one year or older with newly diagnosed Ph chromosome-positive acute lymphoblastic leukemia

Business Model

The IGIA team are experienced drug development professionals. Lois Rosenberger, PhD is the President and owner of LBR Regulatory-Clinical Consulting Services (LBR) and Acting CEO of IGIA Pharmaceutics. LBR is a niche Contract Research Organization (CRO) that will be used by IGIA Pharmaceuticals to administer the Phase 2 drug development program for dasatinib.

This innovative business model has the advantages of using the expertise and successful track record of senior level professionals. Being a niche CRO LBR will develop dasatinib as a priority and can provide cost effective services.