Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Dexmethylphenidate
Therapeutic Area : Sleep
Study Phase : Phase II
Sponsor : Hypersomnia Foundation
Deal Size : Undisclosed
Deal Type : Partnership
KemPharm Partners with the Hypersomnia Foundation to Support Sleep Disorder Research and Advocacy
Details : KP1077 is KemPharm’s lead clinical candidate being developed as a treatment for idiopathic hypersomnia (IH) and narcolepsy. KP1077 is comprised solely of serdexmethylphenidate (SDX), KemPharm’s proprietary prodrug of d-methylphenidate.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Undisclosed
January 18, 2023
Lead Product(s) : Dexmethylphenidate
Therapeutic Area : Sleep
Highest Development Status : Phase II
Sponsor : Hypersomnia Foundation
Deal Size : Undisclosed
Deal Type : Partnership
Lead Product(s) : Dexmethylphenidate
Therapeutic Area : Sleep
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Serdexmethylphenidate (SDX) is KemPharm’s proprietary prodrug of d-methylphenidate (d-MPH) and the sole active pharmaceutical ingredient (API) in KP1077, KemPharm’s lead clinical candidate being developed as a treatment for idiopathic hypersomnia (IH...
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
December 21, 2022
Lead Product(s) : Dexmethylphenidate
Therapeutic Area : Sleep
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dexmethylphenidate
Therapeutic Area : Sleep
Study Phase : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : SDX is the sole active pharmaceutical ingredient (API) in KP1077, KemPharm’s lead clinical candidate being developed as a treatment for IH and narcolepsy.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
November 18, 2022
Lead Product(s) : Dexmethylphenidate
Therapeutic Area : Sleep
Highest Development Status : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Arimoclomol Citrate
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase II/ Phase III
Recipient : Orphazyme
Deal Size : Undisclosed
Deal Type : Acquisition
Details : The acquisition of arimoclomol aligns perfectly with the strategy to build KemPharm’s value via the advancement and commercialization of novel treatments that address rare CNS conditions, including the lead clinical candidate, KP1077 in idiopathic hype...
Product Name : Miplyffa
Product Type : Other Small Molecule
Upfront Cash : $12.8 million
May 15, 2022
Lead Product(s) : Arimoclomol Citrate
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase II/ Phase III
Recipient : Orphazyme
Deal Size : Undisclosed
Deal Type : Acquisition
Lead Product(s) : Dexmethylphenidate
Therapeutic Area : Sleep
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The data suggest that KP1077 (serdexmethylphenidate) produces a smoother, more gradual release of d-MPH that may avoid the adverse events associated with large and rapid exposure fluctuations that may be experienced with other stimulant-based therapies.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
May 05, 2022
Lead Product(s) : Dexmethylphenidate
Therapeutic Area : Sleep
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dexmethylphenidate
Therapeutic Area : Sleep
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Prodrug of d-methylphenidate, is sole API in KP1077, a potential first-ever therapeutic treatment for Idiopathic Hypersomnia, a neurological disorder marked by significant, detrimental effects on nighttime sleep as well as daytime sleepiness/wakefulness.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
April 19, 2022
Lead Product(s) : Dexmethylphenidate
Therapeutic Area : Sleep
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dexmethylphenidate
Therapeutic Area : Sleep
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
KemPharm Announces Full Data Set from Higher-Dose Serdexmethylphenidate (SDX) Phase 1 Clinical Trial
Details : Data demonstrate higher doses of KP1077 (serdexmethylphenidate) prodrug of d-methylphenidate, were generally well-tolerated and produced targeted pharmacodynamic effects that may be beneficial for the treatment of idiopathic hypersomnia and other sleep d...
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
March 21, 2022
Lead Product(s) : Dexmethylphenidate
Therapeutic Area : Sleep
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Donepezil
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Corium
Deal Size : $2.0 million
Deal Type : Agreement
Details : KemPharm is due to receive the fee, within 30 days following FDA approval of ADLARITY, pursuant to a master development services agreement entered into with Corium in July 2020, under which KemPharm provided development related to Corium’s resubmission...
Product Name : Adlarity
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
March 16, 2022
Lead Product(s) : Donepezil
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Corium
Deal Size : $2.0 million
Deal Type : Agreement
Lead Product(s) : Dexmethylphenidate
Therapeutic Area : Sleep
Study Phase : Preclinical
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
KemPharm Completes KP1077 Pre-IND Meeting Process with FDA
Details : The successful completion of the pre-IND meeting process with the FDA for KP1077 affirms company's plan to submit the IND application by mid-year 2022 and to initiate a Phase 2 trial of KP1077 for Idiopathic Hypersomnia.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
February 23, 2022
Lead Product(s) : Dexmethylphenidate
Therapeutic Area : Sleep
Highest Development Status : Preclinical
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : AZSTARYS is a once-daily product for the treatment of ADHD in patients aged six years and older consisting of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
October 27, 2021
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable