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Details:
Ztalmy (ganaxolone) is a positive allosteric modulation of the gamma-aminobutyric acid type A (GABAA) receptor in the CNS. It is used for the treatment of epileptic seizures associated with CDKL5 deficiency disorder.
Lead Product(s): Ganaxolone
Therapeutic Area: Genetic Disease Product Name: Ztalmy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Marinus Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 31, 2023
CPhI Korea
Not Confirmed
Contact SupplierDetails:
Ztalmy (ganaxolone) is a neuroactive steroid that works by modulating both synaptic and extrasynaptic GABAA receptors via a unique binding site to potentiate two types of inhibitory signaling. It is being evaluated for the treatment of refractory status epilepticus.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Product Name: Ztalmy
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 April 15, 2024
Details:
Ztalmy (ganaxolone) is a positive allosteric modulation of the gamma-aminobutyric acid type A (GABAA) receptor in the CNS. It is investigated for the treatment of Seizures Associated With CDKL5 Deficiency Disorder.
Lead Product(s): Ganaxolone
Therapeutic Area: Genetic Disease Product Name: Ztalmy
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 26, 2023
Details:
Ztalmy (ganaxolone) is a positive allosteric modulation of the gamma-aminobutyric acid type A (GABAA) receptor in the CNS. It is investigated for the treatment of lennox-gastaut syndrome.
Lead Product(s): Ganaxolone
Therapeutic Area: Genetic Disease Product Name: Ztalmy
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2023
Details:
Under the terms of the agreement, Tenacia will receive exclusive rights to develop and commercialize certain formulations of Ztalmy (ganaxolone) in Mainland China, Hong Kong, Macau and Taiwan, including the current oral and intravenous (IV) dose formulations.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Product Name: Ztalmy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Tenacia Biotechnology
Deal Size: $266.0 million Upfront Cash: $10.0 million
Deal Type: Collaboration November 17, 2022
Details:
Marinus intends to use the net proceeds of the offering to continue to fund commercialization of ZTALMY® (ganaxolone) oral suspension CV, the development of its product candidates and for general corporate purposes.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Product Name: Ztalmy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: SVB Securities
Deal Size: $60.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering November 07, 2022
Details:
Under the terms of the revenue interest financing agreement, Sagard will provide Marinus with an upfront cash payment in exchange for tiered payments on annual U.S. net sales of ganaxolone, including ZTALMY (ganaxolone).
Lead Product(s): Ganaxolone
Therapeutic Area: Genetic Disease Product Name: Ztalmy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sagard Healthcare Partners
Deal Size: Undisclosed Upfront Cash: $32.5 million
Deal Type: Financing October 31, 2022
Details:
Marinus anticipates using the proceeds for the ZTALMY® (ganaxolone) commercial launch, execution of its Phase 3 clinical programs in refractory status epilepticus and tuberous sclerosis complex, and other general expenditures.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Product Name: Ztalmy
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novo Nordisk
Deal Size: $110.0 million Upfront Cash: $92.3 million
Deal Type: Agreement August 29, 2022
Details:
ZTALMY® (ganaxolone) oral suspension CV is the first and only FDA-approved treatment indicated specifically for seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD) in patients two years of age and older.
Lead Product(s): Ganaxolone
Therapeutic Area: Genetic Disease Product Name: Ztalmy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2022
Details:
Marinus was awarded the voucher when it received approval of ZTALMY® (ganaxolone) oral suspension CV for the treatment of seizures associated with CDKL5 deciency disorder, a rare form of genetic epilepsy.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Product Name: Ztalmy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novo Nordisk
Deal Size: $110.0 million Upfront Cash: Undisclosed
Deal Type: Divestment July 14, 2022
Details:
Ztalmy (Ganaxolone) is a neuroactive steroid GABAA receptor modulator that acts on a well-characterized target in the brain known to have anti-seizure effects.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Product Name: Ztalmy
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 June 08, 2022
Details:
Ztalmy (ganaxolone) is a neuroactive steroid GABA-A receptor modulator that acts on a well-characterized target in the brain known to have anti-seizure effects.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Product Name: Ztalmy
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 May 05, 2022
Details:
ZTALMY, is the first and only FDA-approved treatment indicated specically for seizures associated with cyclindependent kinase-like 5 deciency disorder (CDD) in patients two years of age and older.
Lead Product(s): Ganaxolone
Therapeutic Area: Rare Diseases and Disorders Product Name: Ztalmy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 14, 2022
Details:
Approval of ZTALMY in CDD is based on data from marigold trial, in which 101 patients were randomized and individuals treated with ZTALMY showed a median 30.7% reduction in 28-day major motor seizure frequency, compared to a median 6.9% reduction for those receiving placebo.
Lead Product(s): Ganaxolone
Therapeutic Area: Rare Diseases and Disorders Product Name: Ztalmy
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 18, 2022
Details:
RAISE trial for CCD 1042 (ganaxolone), a positive allosteric modulator of GABA receptor, delayed due to impacts from COVID-19 variant and recent interruption in clinical supply material for the treatment of status epilepticus.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Product Name: CCD 1042
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 February 22, 2022
Details:
Ganaxolone, a positive allosteric modulator of GABAA receptors being developed in intravenous and oral formulations. Ganaxolone exhibits anti-seizure and anti-anxiety activity via its effects on synaptic and extrasynaptic GABAA receptors.
Lead Product(s): Ganaxolone
Therapeutic Area: Genetic Disease Product Name: Ztalmy
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 05, 2021
Details:
Ganaxolone was generally well-tolerated with somnolence reported as the most common adverse event, consistent with previous trials; in addition, one treatment-related serious adverse event of seizure was reported in the trial.
Lead Product(s): Ganaxolone
Therapeutic Area: Genetic Disease Product Name: Undisclosed
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 August 17, 2021
Details:
As part of the agreement, Marinus will continue to be responsible for clinical development of ganaxolone, as well as regulatory approvals and submissions, including interactions with the European Medicines Agency (EMA).
Lead Product(s): Ganaxolone
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Orion Corporation
Deal Size: $145.0 million Upfront Cash: $30.0 million
Deal Type: Collaboration August 03, 2021
Details:
Ganaxolone was generally well-tolerated with a safety prole consistent with previous clinical trials, with the most frequent adverse event being somnolence.
Lead Product(s): Ganaxolone
Therapeutic Area: Genetic Disease Product Name: Undisclosed
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 August 03, 2021
Details:
The RAISE trial is a randomized, double-blind, placebo-controlled trial that will evaluate the efficacy and safety of IV ganaxolone in RSE patients who have failed benzodiazepines and two or more second line intravenous antiepileptic drugs (AEDs).
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Product Name: CCD 1042
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: BARDA
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 26, 2021
Details:
In the Phase 3 Marigold trial, patients treated with ganaxolone showed a significant 32.2% median reduction in 28-day major motor seizure frequency, compared to a 4.0% reduction for those receiving the placebo, achieving the trial’s primary endpoint.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Product Name: CCD 1042
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 January 13, 2021
Details:
Launch of an expanded access program will allow the company to offer ganaxolone to patients with CDKL5 Deficiency Disorder (CDD) who were unable to participate in the company’s Marigold Study Phase 3 clinical trial.
Lead Product(s): Ganaxolone
Therapeutic Area: Genetic Disease Product Name: CCD 1042
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 December 07, 2020
Details:
Four abstracts highlighting clinical trial and research data in the use of ganaxolone in treating CDKL5 deficiency disorder (CDD) and refractory status epilepticus (SE) have been selected for poster presentation at the American Epilepsy Society (AES) Annual Meeting (AES2020).
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Product Name: CCD 1042
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 November 23, 2020
Details:
Marinus Pharmaceuticals has satisfied the FDA’s protocol-specific questions for the registrational Phase 3 trial (the RAISE trial) in refractory status epilepticus (RSE), allowing the company to begin enrollment in this clinical trial.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Product Name: CCD 1042
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 September 24, 2020
Details:
U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for the company’s product candidate ganaxolone for the treatment of CDKL5 deficiency disorder (CDD), a rare refractory form of pediatric epilepsy.
Lead Product(s): Ganaxolone
Therapeutic Area: Genetic Disease Product Name: CCD 1042
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 30, 2020
Details:
Marinus has finalized the protocol for its planned Phase 3 pivotal clinical trial in SE following its End of Phase 2 Meeting held in March 2020 and based on the successful results from its completed Phase 2 trial.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Product Name: Undisclosed
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 June 30, 2020
Details:
Marinus intends to use the net proceeds to fund the development of its product candidates and working capital, capital expenditures, research and development expenditures, clinical trial expenditures, acquisitions of new technologies, products or businesses, and investments.
Lead Product(s): Ganaxolone
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cowen
Deal Size: $40.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering May 28, 2020
Details:
The Marigold Study is a pivotal Phase 3 study evaluating oral ganaxolone in children and young adults with CDKL5 Deficiency Disorder (CDD).
Lead Product(s): Ganaxolone
Therapeutic Area: Genetic Disease Product Name: Undisclosed
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 February 25, 2020
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