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 : KP1077
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 : KP1077
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 : KP1077
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) : 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 : KP1077
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 : KP1077
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 : KP1077
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 : KP1077
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 : KP1077
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
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Gurnet Point Capital
Deal Size : $590.0 million
Deal Type : Licensing Agreement
Details : Gurnet Point Capital affiliate gets exclusive worldwide license to develop, manufacture and commercialize KemPharm’s product candidates containing serdexmethylphenidate (SDX) and d-methylphenidate (d-MPH), including AZSTARYS for the treatment of ADHD.
Product Name : Azstarys
Product Type : Controlled Substance
Upfront Cash : $10.0 million
August 04, 2021
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Gurnet Point Capital
Deal Size : $590.0 million
Deal Type : Licensing Agreement