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Brexanolone
CAS NO.: 516-54-1
Chemical Formula: C21H34O2
Molecular Weight: 318.5000
DMF&GMP status: Please contact us for more details.
Description:
Also named as Allopregnanolone.

Brexanolone is a unique, intravenously administered, neuroactive steroidal antidepressant used in the therapy of moderate-to-severe postpartum depression. In prelicensure clinical trials, brexanolone therapy was not associated with an increased rate of serum aminotransferase elevations, and it has not been linked to instances of clinically apparent acute liver injury.

Brexanolone is a 3-hydroxy-5alpha-pregnan-20-one in which the hydroxy group at position 3 has alpha-configuration. It is a metabolite of the sex hormone progesterone and used for the treatment of postpartum depression in women. It has a role as a human metabolite, an antidepressant, a GABA modulator, an intravenous anaesthetic and a sedative.

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Approvals
Active Ingredient Dosage Form; Route Strength Proprietary Name Applicant
BREXANOLONESOLUTION;INTRAVENOUS100MG/20ML (5MG/ML)ZULRESSOSAGE THERAPEUTICS INC
Patent Data
Patent No. Patent Expiration Drug Substance Claim Drug Product Claim Patent Use Code
763577303/13/2029DP
841007703/13/2029DP
920008803/13/2029DP
975082203/13/2029DP
1011795103/13/2029DP
1025189411/27/2033U-2552
1032213901/23/2033DP
Exclusive Data
Exclusivity Code Exclusivity Expiration
NCE 06/17/2024