Drugs / Lasofoxifene
Lasofoxifene
also known as
CB-336156EB · CP-336,156-CB · CP-336156 · Fablyn · Lasofoxifene d-tartrate · LASOFOXIFENE TARTRATE · Lasofoxifeno · Oporia
Small molecule targets ESR1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed osteoporosis 2 milestones | |||||
| Rejected (CRL) | US (FDA) | FABLYN | osteoporosis | 2009-02-12 | “received a complete response letter from the FDA requesting additional information for FABLYN(R) (lasofoxifene).” ligand.com ↗ |
| Filed | US (FDA) | Fablyn | osteoporosis | — | “Pfizer submitted an NDA for FABLYN(R) (lasofoxifene) in the fourth quarter of 2007.” ligand.com ↗ |
| Withdrawn Indication not stated 2 milestones | |||||
| Withdrawn | EU (EMA) | Fablyn | — | 2012-02-27 | europa.eu ↗ |
| Approved | EU (EMA) | Fablyn | — | 2009-02-24 | europa.eu ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 26 trials · 1 missed | ||||||
| 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 | Missed primary |
| 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 · 1 met primary | ||||||
| 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 | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-04-21 | LeonaBio | Results Independent Nonclinical Research on Lasofoxifene Presented at American Association for Cancer Research Annual Meeting 2026 Consistent with LeonaBio’s Data leonabio.com ↗
Results showed lasofoxifene protected against hormone withdrawal-induced bone loss and maintained a robust anti-tumor response in primary and metastatic animal models of ER+ breast cancer |
| 2024-05-14 | Shanghai Henlius Biotech | Regulatory Henlius lasofoxifene HLX78 IND Approved by NMPA henlius.com ↗
the investigational new drug application (IND) for the clinical trial of HLX78, also known as lasofoxifene, for the treatment of ER+/HER2- breast cancer harboring ESR1 mutation has been approved by the National Medical Products Administration (NMPA) |
| 2014-06-23 | Ligand Pharmaceuticals | Results Ligand Announces Presentation of Positive Data from a Phase 1 Study on the Effect of the SERM Lasofoxifene to Increase Testosterone Levels in Men ligand.com ↗
Single oral doses of lasofoxifene of 1, 3, 10, 30 and 100 mg increased levels of testosterone (T); doses of 30 and 100 mg increased levels of T by more than 80% |
| 2008-01-15 | Ligand Pharmaceuticals | Regulatory Ligand Partner Pfizer Submits NDA for Fablyn(R) ligand.com ↗
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) (the Company or Ligand) today announced that its partner Pfizer, Inc. (NYSE: PFE) has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Fablyn (lasofoxifene tartrate) Tablets (formerly, Oporia), a selective estrogen receptor modulator (SERM) for the treatment of osteoporosis in postmenopausal women. |
All press releases naming this drug 15 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lasofoxifene | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06197568 ↗ |
| 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 |