X
API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
EU WC
0
Listed Suppliers
0
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
KP1077 (serdexmethylphenidate) is a prodrug of d-methylphenidate, which acts as dopamine & norepinephrine transporter antagonists. It is being evaluated for the treatment of idiopathic hypersomnia.
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 March 26, 2024
Details:
KP1077 is 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: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2023
Details:
Azstarys (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) showed no clinically significant impact on weight and height growth rate in pediatric patients. CNS stimulants prescribed for treatment of ADHD have been associated with height and weight growth.
Lead Product(s): Serdexmethylphenidate,Dexmethylphenidate
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 May 22, 2023
Details:
KP1077 is 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: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2023
Details:
KP1077 is Zevra’s lead clinical candidate being developed to treat idiopathic hypersomnia (“IH”) and narcolepsy. KP1077 is comprised solely of serdexmethylphenidate (“SDX”), Zevra’s proprietary prodrug of d-methylphenidate (“d-MPH”).
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 April 04, 2023
Details:
The data being generated by Zevra's program for KP1077 (serdexmethylphenidate), a novel therapy for the treatment of IH, will support the research and development of effective treatments for rare sleep disorders through the use of new data collection platform led by RARE-X.
Lead Product(s): Serdexmethylphenidate
Therapeutic Area: Sleep Product Name: KP1077
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: RARE-X
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 17, 2023
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.
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:
AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) for patients six and older with ADHD, and ADLARITY (donepezil transdermal system) for patients with mild, moderate, or severe dementia of the Alzheimer's type.
Lead Product(s): Serdexmethylphenidate,Dexmethylphenidate
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 September 13, 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:
AZSTARYS is the first and only medicine containing SDX, a prodrug of d-MPH, which provides for an extended duration of d-MPH release throughout the day. Once-daily AZSTARYS is available nationally in the U.S. in three SDX/immediate-release d-MPH dose strengths.
Lead Product(s): Serdexmethylphenidate,Dexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gurnet Point Capital
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 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:
AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) significantly improved attention deficit hyperactivity disorder (ADHD) symptoms.
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 29, 2021
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
Details:
The financing will provide funds to support continued U.S. commercialization of AZSTARYS which is used for the treatment of ADHD for patients 6 years of age and over that was approved by the FDA.
Lead Product(s): Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hercules Capital
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing September 27, 2021
Details:
AZSTARYS is the first and only product containing a dexmethylphenidate (d-MPH) oral prodrug for the treatment of attention deficit hyperactivity disorder (ADHD) symptoms in patients aged six years and older.
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 May 03, 2021
Details:
The License Agreement provides for an exclusive worldwide license to develop, manufacture and commercialize KemPharm’s product candidates containing serdexmethylphenidate and d-methylphenidate (d-MPH), including AZSTARYS.
Lead Product(s): Serdexmethylphenidate,Dexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Commave Therapeutics
Deal Size: $590.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration April 21, 2021
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.
Lead Product(s): Serdexmethylphenidate,Dexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gurnet Point Capital
Deal Size: $590.0 million Upfront Cash: $10.0 million
Deal Type: Licensing Agreement April 08, 2021
Details:
AZSTARYS contains 30 percent immediate-release d-MPH and 70 percent extended-release novel SDX, a prodrug of d-MPH. After absorption via the gastrointestinal tract, SDX is converted to d-MPH with a design to gradually release d-MPH throughout the day.
Lead Product(s): Serdexmethylphenidate,Dexmethylphenidate
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 March 03, 2021
Details:
KP879 is being developed as an extended-duration, agonist replacement therapy for the treatment of Stimulant Use Disorder (SUD), a condition for which there are no FDA-approved medications.
Lead Product(s): Serdexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: KP879
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 January 27, 2021
Details:
KemPharm is developing KP879 as an extended-duration, agonist replacement therapy for the treatment of Stimulant Use Disorder (SUD). If the KP879 IND filing is accepted by the FDA, KemPharm intends to initiate efficacy studies of KP879 in 2021.
Lead Product(s): Serdexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: KP879
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 December 22, 2020
Details:
KP415 is KemPharm’s investigational product candidate for the treatment of attention deficit hyperactivity disorder (ADHD). Serdexmethylphenidate (SDX) is KemPharm’s prodrug of d-methylphenidate (d-MPH).
Lead Product(s): Serdexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: KP415
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
These newly-issued patents have an expiration date of December 9, 2037, which is an extension of approximately five years past the previously-issued patents generally describing compositions based on a prodrug of d-methylphenidate (serdexmethylphenidate or SDX).
Lead Product(s): Serdexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: KP415
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2020
Details:
KP415 is KemPharm’s product candidate for the treatment of attention deficit hyperactivity disorder (ADHD), which contains serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH).
Lead Product(s): Serdexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Corium
Deal Size: $5.0 million Upfront Cash: Not Applicable
Deal Type: Collaboration May 04, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
