Drugs / Lasofoxifene

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Withdrawn EU (EMA) Fablyn 2012-02-27 europa.eu
Approved EU (EMA) Fablyn 2009-02-24 europa.eu

Trials 9 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 26 trials
Phase 2 NCT06197568 Jun → Dec 2026 expected postmenopausal atrophic vaginitis Azure Biotech Inc. Recruiting No outcome recorded
Phase 2 NCT04432454 Sep 2020 → Jan 2025 breast cancer Sermonix Pharmaceuticals Inc. Completed No outcome recorded
Phase 2 NCT03781063 Sep 2019 → May 2025 breast cancer Sermonix Pharmaceuticals Inc. Completed No outcome recorded
Phase 2 NCT01042379 Mar 2010 → Dec 2030 expected HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 QuantumLeap Healthcare Collaborative Recruiting No outcome recorded
Phase 2 NCT00674453 Sep 2004 → Sep 2007 osteoporosis Ligand Pharmaceuticals Completed No outcome recorded
Phase 2 NCT00143273 Jun 2004 → Mar 2006 osteoporosis Ligand Pharmaceuticals Completed No outcome recorded
Phase 33 trials
Phase 3 NCT05696626 Oct 2023 → Apr 2027 expected breast cancer LeonaBio Recruiting No outcome recorded
Phase 3 NCT00163137 May 2003 → Oct 2005 osteoporosis Ligand Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00141323 Nov 2001 → Dec 2007 osteoporosis Ligand Pharmaceuticals Completed No outcome recorded

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 11 sources stand behind the page.

FieldValueCited text
Known as Lasofoxifene ClinicalTrials.gov intervention name — accepted as the source's own label NCT03781063
8

NCT04432454

NCT00674453

NCT00163137

NCT05696626

NCT00141323

NCT06197568

NCT00143273

NCT01042379

Known as CB-336156EB ChEMBL registry synonym — accepted as the source's own label CHEMBL328190
Known as CP-336,156-CB ChEMBL registry synonym — accepted as the source's own label CHEMBL328190
Known as CP-336156 ChEMBL registry synonym — accepted as the source's own label CHEMBL328190
Known as Fablyn ChEMBL registry synonym — accepted as the source's own label CHEMBL328190
Known as Lasofoxifene d-tartrate ChEMBL registry synonym — accepted as the source's own label CHEMBL328190
Known as LASOFOXIFENE TARTRATE ChEMBL registry synonym — accepted as the source's own label CHEMBL328190
Known as Lasofoxifeno ChEMBL registry synonym — accepted as the source's own label CHEMBL328190
Known as Oporia ChEMBL registry synonym — accepted as the source's own label CHEMBL328190
Action Inhibit “Estrogen receptor antagonist antineoplastic agent” NCT03781063
Modality Small molecule CHEMBL328190
Route Oral “0.5 mg once per day, orally” NCT00141323
Target ESR1 “Lasofoxifene, a novel selective ER modulator, stabilizes an antagonist conformation of wild-type and ESR1-mutated ER-ligand binding domains, and has antitumor activity in...” PMID 38072514 Dec 2023