Nuvalent Inc.
Nuvalent is a pioneering biotechnology company with deep expertise in chemistry and structure-based drug discovery, focused on creating precisely targeted therapies for cancer patients. The company aims to address the dual challenges of resistance and selectivity in oncology treatments, leveraging innovative small molecules to inhibit clinically proven kinase targets. Nuvalent's mission is to develop therapies that enable durable responses and improve patient outcomes, supported by a world-class team of scientists and industry veterans.
Industries
Nr. of Employees
medium (51-250)
Patents
Solid forms, pharmaceutical compositions and preparation of heteroaromatic macrocyclic ether compounds
US-12043626-B2
View Details
Solid forms, pharmaceutical compositions and preparation of heteroaromatic macrocyclic ether compounds
US-12043626-B2
View DetailsProducts
Selective ROS1 kinase inhibitor (brain-penetrant)
Small-molecule ROS1-selective kinase inhibitor optimized for selectivity, activity against resistance mutations, and brain penetration to address CNS metastases.
Selective ALK kinase inhibitor (brain-penetrant)
Small-molecule ALK-selective kinase inhibitor optimized for kinase selectivity, CNS penetration, and activity against single and compound resistance mutations.
Selective HER2 kinase inhibitor (brain-penetrant)
Small-molecule HER2-selective kinase inhibitor designed to treat HER2-altered tumors while minimizing inhibition of wild-type EGFR and optimized for brain penetration.
Selective ROS1 kinase inhibitor (brain-penetrant)
Small-molecule ROS1-selective kinase inhibitor optimized for selectivity, activity against resistance mutations, and brain penetration to address CNS metastases.
Selective ALK kinase inhibitor (brain-penetrant)
Small-molecule ALK-selective kinase inhibitor optimized for kinase selectivity, CNS penetration, and activity against single and compound resistance mutations.
Selective HER2 kinase inhibitor (brain-penetrant)
Small-molecule HER2-selective kinase inhibitor designed to treat HER2-altered tumors while minimizing inhibition of wild-type EGFR and optimized for brain penetration.
Services
Design and operational execution support for Phase 1–3 oncology clinical trials, including patient materials and global trial enrollment coordination.
Medical oversight, safety monitoring and operational leadership for first-in-human and early-phase oncology studies, including complex FIH designs.
Design and execution of DMPK/ADME studies, regulated bioanalytical assays and preparation of ADME/PK packages to support IND/NDA filings.
Preclinical programs that include mutagenesis resistance screening and intracranial efficacy models to inform candidate selection and CNS activity potential.
Formulation development, process design, scale-up and technology transfer with oversight of external CDMO manufacturing to produce clinical material.
Risk-based QA programs, vendor and site audits, corrective action oversight and support for health authority inspections related to GCP and pharmacovigilance.
Design and operational execution support for Phase 1–3 oncology clinical trials, including patient materials and global trial enrollment coordination.
Medical oversight, safety monitoring and operational leadership for first-in-human and early-phase oncology studies, including complex FIH designs.
Design and execution of DMPK/ADME studies, regulated bioanalytical assays and preparation of ADME/PK packages to support IND/NDA filings.
Preclinical programs that include mutagenesis resistance screening and intracranial efficacy models to inform candidate selection and CNS activity potential.
Formulation development, process design, scale-up and technology transfer with oversight of external CDMO manufacturing to produce clinical material.
Risk-based QA programs, vendor and site audits, corrective action oversight and support for health authority inspections related to GCP and pharmacovigilance.
Expertise Areas
- Oncology drug discovery
- Kinase inhibitor development
- CNS‑penetrant oncology therapeutics
- Translational research and target selection
Key Technologies
- Structure-based drug design
- Small-molecule kinase inhibitors
- Medicinal chemistry for CNS penetration
- ADME/PK and DMPK studies