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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.
Lead Product(s): Serdexmethylphenidate
Therapeutic Area: Sleep Product Name: KP1077
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hypersomnia Foundation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership January 18, 2023
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) and narcolepsy.
Lead Product(s): Serdexmethylphenidate
Therapeutic Area: Sleep Product Name: KP1077
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2022
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.
Lead Product(s): Serdexmethylphenidate
Therapeutic Area: Sleep Product Name: KP1077
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2022
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 hypersomnia.
Lead Product(s): Arimoclomol
Therapeutic Area: Rare Diseases and Disorders Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Recipient: Orphazyme
Deal Size: Undisclosed Upfront Cash: $12.8 million
Deal Type: Acquisition May 15, 2022
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.
Lead Product(s): Serdexmethylphenidate
Therapeutic Area: Sleep Product Name: KP1077
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2022
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.
Lead Product(s): Methylphenidate
Therapeutic Area: Sleep Product Name: KP1077
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2022
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 disorders.
Lead Product(s): Serdexmethylphenidate
Therapeutic Area: Sleep Product Name: KP1077
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2022
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 of its NDA for ADLARITY.
Lead Product(s): Donepezil
Therapeutic Area: Neurology Product Name: Adlarity
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Corium
Deal Size: $2.0 million Upfront Cash: Undisclosed
Deal Type: Agreement March 16, 2022
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.
Lead Product(s): Dexmethylphenidate
Therapeutic Area: Sleep Product Name: KP1077
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2022
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.
Lead Product(s): Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2021
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