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Ganaxolone

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ACTIVE PHARMA INGREDIENTS

6 API Suppliers, 2 NDC API, 6 Listed Suppliers

6 API Suppliers
2 NDC API
6 Listed Suppliers

DEVELOPMENTS

31 Drugs in Development

31 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1 FDF Dossiers, 1 FDA Orange Book

1 FDF Dossiers
1 FDA Orange Book

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 32 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
32 NEWS #PharmaBuzz

PATENTS & EXCLUSIVITIES

8 US Patents, 2 US Exclusivities

patents
8 US Patents
2 US Exclusivities

Synopsis

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FDF Dossiers

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Canada

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Listed Dossiers

31DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

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PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

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Chemistry

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Also known as: 38398-32-2, Ccd 1042, Ztalmy, Ccd-1042, 3alpha-hydroxy-3beta-methyl-5alpha-pregnan-20-one, 98wi44ohiq

Molecular Formula

C₂₂H₃₆O₂

Molecular Weight

332.5 g/mol

InChI Key

PGTVWKLGGCQMBR-FLBATMFCSA-N

FDA UNII

98WI44OHIQ

Ganaxolone is an orally bioavailable synthetic analog of the neuroactive steroid allopregnanolone and positive allosteric modulator of the gamma-aminobutyric acid (GABA)-A receptor, with anxiolytic, sedative, antidepressant and anticonvulsant activities. Upon oral administration, ganaxolone specifically targets and binds to the allosteric sites of the synaptic and extrasynaptic GABA-A receptor-chloride ionophore complex in the central nervous system (CNS). This leads to an increase in the opening of chloride channels, membrane hyperpolarization, increases the inhibitory effect of GABA on the CNS, and inhibits neurotransmission. This blocks seizure propagation and elevates seizure thresholds.

1 2D Structure

Ganaxolone

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

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

2.1.2 InChI

InChI=1S/C22H36O2/c1-14(23)17-7-8-18-16-6-5-15-13-20(2,24)11-12-21(15,3)19(16)9-10-22(17,18)4/h15-19,24H,5-13H2,1-4H3/t15-,16-,17+,18-,19-,20+,21-,22+/m0/s1

2.1.3 InChI Key

PGTVWKLGGCQMBR-FLBATMFCSA-N

2.1.4 Canonical SMILES

CC(=O)C1CCC2C1(CCC3C2CCC4C3(CCC(C4)(C)O)C)C

2.1.5 Isomeric SMILES

CC(=O)[C@H]1CC[C@@H]2[C@@]1(CC[C@H]3[C@H]2CC[C@@H]4[C@@]3(CC[C@@](C4)(C)O)C)C

2.2 Other Identifiers

2.2.1 UNII

98WI44OHIQ

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 3alpha-hydroxy-3beta-methyl-5alpha-pregnan-20-one

2. Ccd 1042

3. Ccd-1042

4. Ztalmy

2.3.2 Depositor-Supplied Synonyms

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.

2.4 Create Date

2006-07-28

3 Chemical and Physical Properties

Molecular Formula	C₂₂H₃₆O₂
Molecular Weight	332.5 g/mol
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 Å²
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

4 Drug and Medication Information

4.1 Drug Indication

Investigated for use/treatment in pediatric indications and seizure disorders.

Treatment of cyclin-dependent kinase-like 5 deficiency disorder

5 Pharmacology and Biochemistry

5.1 Pharmacology

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).

5.2 MeSH Pharmacological Classification

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.)

5.3 ATC Code

N - Nervous system

N03 - Antiepileptics

N03A - Antiepileptics

N03AX - Other antiepileptics

N03AX27 - Ganaxolone

5.4 Biological Half-Life

1.3-1.9 hours

5.5 Mechanism of Action

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.

API SUPPLIERS

01

Aspen API

Netherlands

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

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Netherlands

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

Nuray Chemicals Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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India

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

03

Seqens

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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France

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USDMF CEP/COS JDMF EU-WC NDC

KDMF VMF Others AUDIT

04

Sterling Spa

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

05

Curia

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

06

Curia

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

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NDC API

01

Wavelength Enterprises Ltd

France

Medlab Asia & Asia Health

Not Confirmed

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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France

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GANAXOLONE

NDC Package Code : 58175-0654

Start Marketing Date : 2023-11-15

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

02

ScinoPharm Taiwan Ltd.

Taiwan

Medlab Asia & Asia Health

Not Confirmed

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Listed Suppliers

01

Aspen API

Netherlands

Medlab Asia & Asia Health

Not Confirmed

Aspen API. More than just an API.

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Netherlands

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Ganaxolone

About the Company : Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen...

Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen API works tirelessly to deliver top-quality APIs to clients worldwide. Aspen API has a portfolio of over 58 high-quality APIs, including high potency, oncology, peptides, narcotics, analgesics, botanical extractions, and biochemicals. Aspen API places a strong emphasis on sustainability. It employs eco-friendly technologies and solvents in its chemical processes, ensuring responsible and environmentally conscious manufacturing.

02

Nuray Chemicals Private Limited

India

Medlab Asia & Asia Health

Not Confirmed

Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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Ganaxolone

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...

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 the Indian state of Tamil Nadu. Nuray’s expertise and experience lie in developing the chemistry requirements of the pharmaceutical industry, including the synthesis of NCEs, impurities, metabolites, method development, advanced intermediates and APIs for commercial launch. With its focus on maintaining the highest levels of quality, reliability and transparency, Nuray has emerged as a trusted partner in the global generic market.

03

Seqens

France

Medlab Asia & Asia Health

Not Confirmed

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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France

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Ganaxolone

About the Company : Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling ...

Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling up and manufacturing drug substances from the pre-clinical phase to the commercial phase. It offers a large portfolio of APIs and proprietary products. Seqens also develops custom solutions and ingredients for the most demanding industries, such as healthcare, electronics and cosmetics. Its unique range of technologies enables it to manufacture complex molecules for small- and large-scale demands. It operates 24 industrial plants and 10 R&D centres across the globe.

04

Curia

U.S.A

Medlab Asia & Asia Health

Not Confirmed

05

Curia

U.S.A

Medlab Asia & Asia Health

Not Confirmed

06

Sterling Spa

Italy

Medlab Asia & Asia Health

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Drugs in Development

01 Orion Corporation

Finland

Medlab Asia & Asia Health

Not Confirmed

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Lead Product(s) : Ganaxolone

Therapeutic Area : Genetic Disease

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Marinus Pharmaceuticals

Deal Size : Not Applicable

Deal Type : Not Applicable

DEALS_DEV

European Commission Approval of Ztalmy (ganaxolone) for the Adjunctive Treatment of Epileptic Seiz...

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.

Brand Name : Ztalmy

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 31, 2023