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  1. pharmadog
  2. ›drugs
  3. ›Brlizio
drug · small molecule
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brexanolone

Marketedupdated 3mo ago
by $LPCN Lipocine Inc.🔗 ChEMBL
Approved
community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 10 investigational indications.

indications

investigational
Alzheimer's Disease

targets

GABA-A receptor; anion channel

all catalysts(0)

nothing on the calendar yet

Trials studying brexanolone

  • phase1Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorderactive not recruitingn=25
  • phase3A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)completedn=28
  • —Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depressionapproved for marketing
  • phase2An Open-Label Study Evaluating Brexanolone in Adults With Tinnituscompletedn=10
  • phase2Brexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Studynot yet recruitingn=40
  • —Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depressioncompletedn=10
  • EP1Effects Zulresso on Postpartum Psychosiscompletedn=10
  • phase4An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorderrecruitingn=20
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Mar 13, 2029
~2.6 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (8)

  • Mar 8, 2037method-of-use (U-2552)US 10940156
  • Nov 27, 2033method-of-use (U-2552)US 10251894
  • Jan 23, 2033formulationUS 10322139
  • Mar 13, 2029formulationUS 101179512.6y
  • Mar 13, 2029formulationUS 76357732.6y
  • Mar 13, 2029formulationUS 84100772.6y
  • Mar 13, 2029formulationUS 92000882.6y
  • Mar 13, 2029formulationUS 97508222.6y

News(1)

  • Two biotechs raise a combined $556M in latest spurt of IPOs
    Seaport Therapeutics and Hemab Therapeutics on Thursday became the latest drugmakers to debut on Wall Street, continuing a stretch of large IPOs this year that collectively raised almost $3.2 billion.
    biopharma_dive · 3mo ago
brand
Brlizio
trade names
Zulresso
generic
brexanolone
MOA
GABA-A receptor; anion channel positive allosteric modulator
indication
Post Partum Depression (Maternal Depression / Postnatal Depression)
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 5m ago
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