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Estradiol/progesterone - TherapeuticsMD

Drug Profile

Estradiol/progesterone - TherapeuticsMD

Alternative Names: 17β-estradiol/progesterone -TherapeuticsMD; BIJUVA; BIJUVE; E2/P4; Estradiol and progesterone; Progesterone/estradiol - TherapeuticsMD; TX 12-001-HR; TX-001HR; TX-001HR: BIJUVA™; TX-006HR; TX-008HR; TX-009HR

Latest Information Update: 25 Mar 2022

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At a glance

  • Originator TherapeuticsMD
  • Developer Knight Therapeutics; Theramex; TherapeuticsMD
  • Class Estradiol congeners; Estrenes; Hormonal replacements; Pregnenediones
  • Mechanism of Action Estrogen receptor agonists; Progesterone receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Menopausal syndrome
  • Phase III Endometrial hyperplasia

Most Recent Events

  • 24 Mar 2022 Suspended - Preclinical for Endometrial hyperplasia in USA (Topical)
  • 24 Mar 2022 Suspended - Preclinical for Menopausal syndrome in USA (Topical)
  • 28 Dec 2021 US FDA approves sNDA for estradiol/progesterone for Menopausal syndrome (PO, Capsule) (0.5 mg/100 mg)
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