Wednesday, July 8, 2026

Drug profile · INN

ganaxolone

ganaxolone (ZTALMY) is a gaba-a receptor; anion channel positive allosteric modulator. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Nervous system (N03) N03AX
US status approved
Patents linked 2
Pipeline programs 0
News articles 1
Drug details — ganaxolone
US status
approved
Class
Nervous system (N03)
Route
ORAL
Patents
2
Programs
0
Data quality
0.84

Quick answer

ganaxolone (ZTALMY) is a gaba-a receptor; anion channel positive allosteric modulator. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN ganaxolone
Brand ZTALMY
Mechanism GABA-A receptor; anion channel positive allosteric modulator
Target GABA-A receptor; anion channel
Therapeutic class Nervous system (N03)
Route ORAL
Formulation SUSPENSION
ATC code N03AX

Mechanism of action

GABA-A receptor; anion channel positive allosteric modulator

Primary target: GABA-A receptor; anion channel

Approval history

Authority Status Date
FDA approved
EMA approved

Recent coverage

Related & competitor drugs

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  2. alprazolam GABA-A receptor; anion channel positive allosteric modulator
  3. aripiprazole Nervous system (N05)
  4. brexpiprazole Nervous system (N05)
  5. brivaracetam Nervous system (N03)
  6. bupivacaine Nervous system (N01)

Related patents

  1. US 12144801

    Methods and compositions for treatment of epileptic disorders

    Expires Mon Nov 14 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 10603308

    Methods and compositions for treatment of epileptic disorders

    Expires Mon Mar 26 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is ganaxolone?

ganaxolone (ZTALMY) is a gaba-a receptor; anion channel positive allosteric modulator. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for ganaxolone?

ZTALMY is a marketed brand name for ganaxolone. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ganaxolone?

ganaxolone has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.