Technology

LAT™ Prodrug Platform

KemPharm's strategy is to employ its LAT™ (Ligand Activated Therapy) platform technology to discover and develop NME prodrugs that improve one or more of the attributes of approved drugs, such as susceptibility to abuse, bioavailability and safety. KemPharm’s intent is to develop prodrugs that have improved properties over approved drugs and address unmet medical needs in large, established markets.

We use our LAT™ platform technology to create NME prodrugs by chemically attaching one or more molecules, or ligands, to an FDA-approved parent drug. When combined with the parent drug, our ligands create prodrugs designed to have improved drug attributes while maintaining efficacy equivalent to the parent drug.  Once administered, targeted human metabolic processes, such as those in the GI tract, separate the ligand from the prodrug and release the parent drug, which can then exert its therapeutic effect.

The ligands that we typically use have been demonstrated to be safe in toxicological studies or have been granted Generally Recognized as Safe (GRAS) status by the FDA. Further, since our prodrugs are chemical successors of the parent drugs, they are considered to be NMEs and thus may be eligible for protection by composition-of-matter patents. 

KemPharm has employed its LAT™ prodrug platform to create a portfolio of product candidates that we believe will offer significant improvements over FDA-approved and widely prescribed drugs.

 

Selected KemPharm NME Prodrug Product Candidates  

Product Candidate Parent Drug Development Status Next Milestone Potential NDA Submission

ADHD

KP415 Methylphenidate (ER) Clinical PK + Efficacy Data 2018
KP484 Methylphenidate (ER) Clinical PK + Efficacy Data 2019

Pain

Apadaz Hydrocodone/APAP NDA Resubmitted PDUFA (Feb. 23, 2018) Completed
KP201/IR Hydrocodone Clinical IN HAL Data 2018 with Priority Review
KP511/ER Hydromorphone Clinical POC in ER Formulation 2019 with Priority Review
KP511/IR Hydromorphone Clinical HAL + BE Data 2019 with Priority Review
KP606/IR Oxycodone Preclinical Preclinical Development TBD
KP746 Oxymorphone Preclinical Preclinical Development TBD

Multiple CNS Disorders

KP303 Quetiapine Preclinical Preclinical Development TBD