Synopsis
Synopsis
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EU WC
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VMF
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EDQM
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Europe
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1. 3alpha-hydroxy-3beta-methyl-5alpha-pregnan-20-one
2. Ccd 1042
3. Ccd-1042
4. Ztalmy
1. 38398-32-2
2. Ccd 1042
3. Ztalmy
4. Ccd-1042
5. 3alpha-hydroxy-3beta-methyl-5alpha-pregnan-20-one
6. 98wi44ohiq
7. 1-((3r,5s,8r,9s,10s,13s,14s,17s)-3-hydroxy-3,10,13-trimethylhexadecahydro-1h-cyclopenta[a]phenanthren-17-yl)ethanone
8. 1-[(3r,5s,8r,9s,10s,13s,14s,17s)-3-hydroxy-3,10,13-trimethyl-1,2,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydrocyclopenta[a]phenanthren-17-yl]ethanone
9. Pregnan-20-one, 3-hydroxy-3-methyl-, (3a,5a)-
10. Ncgc00165802-02
11. Dsstox_cid_26503
12. Dsstox_rid_81672
13. Dsstox_gsid_46503
14. 1-((3r,5s,8r,9s,10s,13s,14s,17s)-3-hydroxy-3,10,13-trimethylhexadecahydro-1h-cyclopenta[a]phenanthren-17-yl)ethan-1-one
15. Cas-38398-32-2
16. Ganaxolone [usan]
17. Ganaxolone [usan:inn]
18. Unii-98wi44ohiq
19. Ganaxolone, Solid
20. Ganaxolone [mi]
21. Ganaxolone [inn]
22. Ganaxolone (usan/inn)
23. Ganaxolone [who-dd]
24. Schembl144522
25. (3alpha,5alpha)-3-hydroxy-3-methylpregnan-20-one
26. Chembl1568698
27. Dtxsid6046503
28. Gtpl11942
29. Ccd1042
30. Chebi:177658
31. Dea No. 2401
32. Hms3261k19
33. Amy38916
34. Zinc3824281
35. Tox21_112264
36. Tox21_500379
37. Bdbm50369240
38. Mfcd09971088
39. Akos027327586
40. Tox21_112264_1
41. Ccg-221683
42. Db05087
43. Lp00379
44. Sdccgsbi-0633706.p001
45. Ncgc00165802-03
46. Ncgc00261064-01
47. Ncgc00263545-01
48. As-35253
49. B7092
50. (3?,5?)-3-hydroxy-3-methyl-pregnan-20-one
51. 3alpha-hydroxy-3-methyl-5alpha-pregnan-20-one
52. D04300
53. A901692
54. (3alpha,5alpha)-3-hydroxy-3-methyl-pregnan-20-one
55. Q3758034
56. 3.alpha.-hydroxy-3-methyl-5.alpha.-pregnan-20-one
57. Pregnan-20-one, 3-hydroxy-3-methyl-, (3alpha,5alpha)-
58. Pregnan-20-one, 3-hydroxy-3-methyl-, (3.alpha.,5.alpha.)-
59. 1-[(3r,5s,8r,9s,10s,13s,14s,17s)-3-hydroxy-3,10,13-trimethyl-1,2,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydrocyclopenta[a]phenanthren-17-yl]ethanone.
Molecular Weight | 332.5 g/mol |
---|---|
Molecular Formula | C22H36O2 |
XLogP3 | 5 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 1 |
Exact Mass | 332.271530387 g/mol |
Monoisotopic Mass | 332.271530387 g/mol |
Topological Polar Surface Area | 37.3 Ų |
Heavy Atom Count | 24 |
Formal Charge | 0 |
Complexity | 542 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 8 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Investigated for use/treatment in pediatric indications and seizure disorders.
Treatment of cyclin-dependent kinase-like 5 deficiency disorder
Ganaxolone is a powerful positive allosteric modulator of GABAA receptors with potency and efficacy comparable to its endogenous analog 3a,5a-P (Carter et al., 1997). As with 3a,5a-P, Ganaxolone potentiation of the GABAA receptor occurs at a site distinct from the benzodiazepine site. Ganaxolone has protective activity in diverse rodent seizure models, including clonic seizures induced by pentylenetetrazol (PTZ) and bicuculline (BIC), limbic seizures in the 6 Hz model, and amygdala kindled seizures (Carter et al., 1997; Rogawski and Reddy, 2004; Kaminski et al., 2004).
GABA Modulators
Substances that do not act as agonists or antagonists but do affect the GAMMA-AMINOBUTYRIC ACID receptor-ionophore complex. GABA-A receptors (RECEPTORS, GABA-A) appear to have at least three allosteric sites at which modulators act: a site at which BENZODIAZEPINES act by increasing the opening frequency of GAMMA-AMINOBUTYRIC ACID-activated chloride channels; a site at which BARBITURATES act to prolong the duration of channel opening; and a site at which some steroids may act. GENERAL ANESTHETICS probably act at least partly by potentiating GABAergic responses, but they are not included here. (See all compounds classified as GABA Modulators.)
Neurosteroids
Endogenous compounds or drugs that affect neuronal excitability through modulation of specific ionotropic receptors (e.g., GABA-A RECEPTORS). Endogenous neurosteroids are steroid hormones de novo synthesized by neurons and glial cells from steroid metabolite precursors (e.g., PREGNENOLONE). (See all compounds classified as Neurosteroids.)
N - Nervous system
N03 - Antiepileptics
N03A - Antiepileptics
N03AX - Other antiepileptics
N03AX27 - Ganaxolone
1.3-1.9 hours
Ganaxolone belongs to a novel class of neuroactive steroids called epalons, which specifically modulate the -aminobutyric acid type A (GABAA) receptor in the central nervous system (CNS). Chemically related to progesterone but devoid of any hormonal activity, the epalons have potent antiepileptic, anxiolytic, sedative, and hypnotic activities in animals.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
NDC Package Code : 0009-1005
Start Marketing Date : 2023-10-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65129-3162
Start Marketing Date : 2021-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 0009-1005
Start Marketing Date : 2023-10-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65129-3162
Start Marketing Date : 2021-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
About the Company : Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners tur...
About the Company : Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners tur...
About the Company : The Quality Assurance department is the Guardian of Quality within the Company. We have a team dedicated to identifying and implementing new ICH guidelines. Our team is prepared ...
Details:
under the termination agreement, Marinus regains Ztalmy (ganaxolone) rights in Europe. It is approved for the adjunctive treatment of epileptic seizures associated with CDKL5 deficiency disorder.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Brand Name: Ztalmy
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Marinus Pharmaceuticals
Deal Size: $1.5 million Upfront Cash: Undisclosed
Deal Type: Termination December 30, 2024
Lead Product(s) : Ganaxolone
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Marinus Pharmaceuticals
Deal Size : $1.5 million
Deal Type : Termination
Orion and Marinus Terminate Agreement for Ganaxolone in Europe
Details : under the termination agreement, Marinus regains Ztalmy (ganaxolone) rights in Europe. It is approved for the adjunctive treatment of epileptic seizures associated with CDKL5 deficiency disorder.
Product Name : Ztalmy
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
December 30, 2024
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: Rare Diseases and Disorders Brand Name: Ztalmy
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Marinus Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 31, 2023
Lead Product(s) : Ganaxolone
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Marinus Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Ztalmy
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 31, 2023
Details:
Through the acquisition, Immedica strengthens it's global rare disease business by adding Ztalmy (ganaxalone). It is indicated for the treatment of seizures associated with CDKL5 deficiency disorder.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Brand Name: Ztalmy
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Immedica Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition December 30, 2024
Lead Product(s) : Ganaxolone
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Immedica Pharma
Deal Size : Undisclosed
Deal Type : Acquisition
Immedica to Acquire Biopharmaceutical Company Marinus Pharmaceuticals, Inc.
Details : Through the acquisition, Immedica strengthens it's global rare disease business by adding Ztalmy (ganaxalone). It is indicated for the treatment of seizures associated with CDKL5 deficiency disorder.
Product Name : Ztalmy
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
December 30, 2024
Details:
Ztalmy (ganaxolone) is a neuroactive steroid that targets GABAA receptors via a unique binding site. It is being evaluated for the treatment of TSC-related epilepsy.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Brand Name: Ztalmy
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 24, 2024
Lead Product(s) : Ganaxolone
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Marinus to End Further Ztalmy Development After Another Trial Miss
Details : Ztalmy (ganaxolone) is a neuroactive steroid that targets GABAA receptors via a unique binding site. It is being evaluated for the treatment of TSC-related epilepsy.
Product Name : Ztalmy
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 24, 2024
Details:
Ztalmy (ganaxolone) is a neuroactive steroid GABAA receptor PAM, indicated for epileptic seizures in patients two years of age and older with CDKL5 deficiency disorder.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Brand Name: Ztalmy
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Tenacia Biotechnology
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 18, 2024
Lead Product(s) : Ganaxolone
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Tenacia Biotechnology
Deal Size : Inapplicable
Deal Type : Inapplicable
Marinus Announces Ganaxolone Approved in China for CDKL5 Deficiency Disorder
Details : Ztalmy (ganaxolone) is a neuroactive steroid GABAA receptor PAM, indicated for epileptic seizures in patients two years of age and older with CDKL5 deficiency disorder.
Product Name : Ztalmy
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 18, 2024
Details:
Ztalmy (ganaxolone) is a neuroactive steroid that targets GABAA receptors via a unique binding site. It is being evaluated for the treatment of refractory status epilepticus.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Brand Name: Ztalmy
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 17, 2024
Lead Product(s) : Ganaxolone
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Marinus Announces Topline Results from Ph 3 Trial of IV Ganaxolone in Status Epilepticus
Details : Ztalmy (ganaxolone) is a neuroactive steroid that targets GABAA receptors via a unique binding site. It is being evaluated for the treatment of refractory status epilepticus.
Product Name : Ztalmy
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 17, 2024
Details:
Ztalmy (ganaxolone) is a neuroactive steroid modulating both synaptic and extrasynaptic GABAA receptors to treat refractory status epilepticus.
Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Brand Name: Ztalmy
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 15, 2024
Lead Product(s) : Ganaxolone
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Marinus Pharmaceuticals Provides Update On Phase 3 Raise Trial and Financial Results
Details : Ztalmy (ganaxolone) is a neuroactive steroid modulating both synaptic and extrasynaptic GABAA receptors to treat refractory status epilepticus.
Product Name : Ztalmy
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
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: Rare Diseases and Disorders Brand Name: Ztalmy
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 26, 2023
Lead Product(s) : Ganaxolone
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Marinus Pharmaceuticals Receives Positive CHMP Opinion for ZTALMY® (ganaxolone) for the Adjunctiv...
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.
Product Name : Ztalmy
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
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: Rare Diseases and Disorders Brand Name: Ztalmy
Study Phase: PreclinicalProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 22, 2023
Lead Product(s) : Ganaxolone
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Ztalmy
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
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 Brand Name: Ztalmy
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Tenacia Biotechnology
Deal Size: $266.0 million Upfront Cash: $10.0 million
Deal Type: Collaboration November 17, 2022
Lead Product(s) : Ganaxolone
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Tenacia Biotechnology
Deal Size : $266.0 million
Deal Type : Collaboration
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 formulat...
Product Name : Ztalmy
Product Type : Other Small Molecule
Upfront Cash : $10.0 million
November 17, 2022
Regulatory Info : RX
Registration Country : USA
Brand Name : ZTALMY
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 50MG/ML
Packaging :
Approval Date : 2022-06-01
Application Number : 215904
Regulatory Info : RX
Registration Country : USA
RLD : Yes
TE Code :
Brand Name : ZTALMY
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 50MG/ML
Approval Date : 2022-06-01
Application Number : 215904
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
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Patents & EXCLUSIVITIES
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PharmaCompass offers a list of Ganaxolone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ganaxolone manufacturer or Ganaxolone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ganaxolone manufacturer or Ganaxolone supplier.
PharmaCompass also assists you with knowing the Ganaxolone API Price utilized in the formulation of products. Ganaxolone API Price is not always fixed or binding as the Ganaxolone Price is obtained through a variety of data sources. The Ganaxolone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ganaxolone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ganaxolone, including repackagers and relabelers. The FDA regulates Ganaxolone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ganaxolone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Ganaxolone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ganaxolone supplier is an individual or a company that provides Ganaxolone active pharmaceutical ingredient (API) or Ganaxolone finished formulations upon request. The Ganaxolone suppliers may include Ganaxolone API manufacturers, exporters, distributors and traders.
click here to find a list of Ganaxolone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Ganaxolone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ganaxolone API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Ganaxolone as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Ganaxolone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ganaxolone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ganaxolone suppliers with NDC on PharmaCompass.
Ganaxolone Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Ganaxolone GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Ganaxolone GMP manufacturer or Ganaxolone GMP API supplier for your needs.
A Ganaxolone CoA (Certificate of Analysis) is a formal document that attests to Ganaxolone's compliance with Ganaxolone specifications and serves as a tool for batch-level quality control.
Ganaxolone CoA mostly includes findings from lab analyses of a specific batch. For each Ganaxolone CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Ganaxolone may be tested according to a variety of international standards, such as European Pharmacopoeia (Ganaxolone EP), Ganaxolone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ganaxolone USP).