Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Serdexmethylphenidate
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.
Brand Name : KP1077
Molecule Type : Small molecule
Upfront Cash : Undisclosed
January 18, 2023
Lead Product(s) : Serdexmethylphenidate
Therapeutic Area : Sleep
Highest Development Status : Phase II
Sponsor : Hypersomnia Foundation
Deal Size : Undisclosed
Deal Type : Partnership
Lead Product(s) : Serdexmethylphenidate
Therapeutic Area : Sleep
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : KP1077
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 21, 2022
Lead Product(s) : Serdexmethylphenidate
Therapeutic Area : Sleep
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Serdexmethylphenidate
Therapeutic Area : Sleep
Study Phase : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : KP1077
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 18, 2022
Lead Product(s) : Serdexmethylphenidate
Therapeutic Area : Sleep
Highest Development Status : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Arimoclomol
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...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : $12.8 million
May 15, 2022
Lead Product(s) : Arimoclomol
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase II/ Phase III
Recipient : Orphazyme
Deal Size : Undisclosed
Deal Type : Acquisition
Lead Product(s) : Serdexmethylphenidate
Therapeutic Area : Sleep
Study Phase : Phase I
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : KP1077
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 05, 2022
Lead Product(s) : Serdexmethylphenidate
Therapeutic Area : Sleep
Highest Development Status : Phase I
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Methylphenidate
Therapeutic Area : Sleep
Study Phase : Phase I
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : KP1077
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 19, 2022
Lead Product(s) : Methylphenidate
Therapeutic Area : Sleep
Highest Development Status : Phase I
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Serdexmethylphenidate
Therapeutic Area : Sleep
Study Phase : Phase I
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : KP1077
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 21, 2022
Lead Product(s) : Serdexmethylphenidate
Therapeutic Area : Sleep
Highest Development Status : Phase I
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : Adlarity
Molecule Type : Small molecule
Upfront Cash : Undisclosed
March 16, 2022
Lead Product(s) : Dexmethylphenidate
Therapeutic Area : Sleep
Study Phase : Preclinical
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : KP1077
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 23, 2022
Lead Product(s) : Dexmethylphenidate
Therapeutic Area : Sleep
Highest Development Status : Preclinical
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Azstarys
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 27, 2021
Lead Product(s) : Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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