Drugs / Zoledronate
last change Jun 2026 re-read 9 days ago

Zoledronate

also known as zol · AXS-02

Other / unclassified

Developed for
breast cancer · osteoporosis · acute lymphoblastic leukemia · acute myeloid leukemia · cervical cancer · complex regional pain syndrome type 1 · disease related to hematopoietic stem cell transplant · Ewing sarcoma
+17 more · Hodgkins lymphoma · humoral hypercalcemia of malignancy · metastatic malignant neoplasm · myelodysplastic syndrome · neuroblastoma · osteosarcoma · pneumonia · postmenopausal osteoporosis · precancerous condition · prostate cancer · renal cell carcinoma · rhabdomyosarcoma · triple-negative breast carcinoma · castration-resistant prostate carcinoma · metastatic neoplasm · plasma cell myeloma · spondylolisthesis
Investigated by
Associazione Italiana per la Ricerca sul Cancro · Mario Negri Institute for Pharmacological Research · National Cancer Institute (NCI) · Axsome Therapeutics, Inc. · Barbara Ann Karmanos Cancer Institute · Caritas Medical Centre, Hong Kong
+17 more · Children's Hospital Medical Center, Cincinnati · First Affiliated Hospital, Sun Yat-Sen University · HaEmek Medical Center, Israel · M.D. Anderson Cancer Center · Medical University of Vienna · National Institute of Allergy and Infectious Diseases (NIAID) · National Taiwan University Hospital · Novartis Pharmaceuticals · Prince of Wales Hospital, Shatin, Hong Kong · Queen Mary Hospital, Hong Kong · SWOG Cancer Research Network · The University of Hong Kong · United Christian Hospital · United States Department of Defense · University Hospital, Toulouse · University of California, San Francisco · University of Wisconsin, Madison

Trials 16

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT07375290 Feb 2026 → Jan 2028 expected disease related to hematopoietic stem cell transplant Children's Hospital Medical Center, Cincinnati Recruiting No outcome recorded
Phase 1 NCT02508038 Feb 2016 → Dec 2026 expected Ewing sarcoma, Hodgkins lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia +4 University of Wisconsin, Madison Recruiting No outcome recorded
Phase 1 NCT00278434 Apr 2005 → Jul 2008 cervical cancer, precancerous condition University of California, San Francisco Terminated No outcome recorded Stop: Enrollment
Phase 25 trials
Phase 2 NCT03358017 Mar 2018 → Jun 2021 triple-negative breast carcinoma Mario Negri Institute for Pharmacological Research Completed No outcome recorded
Phase 2 NCT02347163 Feb 2015 → Jun 2018 breast cancer Mario Negri Institute for Pharmacological Research Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT01067989 Mar 2010 → Apr 2014 breast cancer HaEmek Medical Center, Israel Terminated No outcome recorded
Phase 2 NCT00490698 Oct 2006 → Jan 2012 renal cell carcinoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 2 NCT00102908 May 2005 → Oct 2007 HIV infectious disease, osteoporosis National Institute of Allergy and Infectious Diseases (NIAID) Unknown No outcome recorded
Phase 32 trials
Phase 3 NCT02504008 Jul 2015 → Jan 2019 complex regional pain syndrome type 1 Axsome Therapeutics, Inc. Unknown No outcome recorded
Phase 3 NCT00301886 May 2006 breast cancer, humoral hypercalcemia of malignancy, metastatic malignant neoplasm SWOG Cancer Research Network Withdrawn No outcome recorded
Phase 43 trials
Phase 4 NCT06767150 Oct 2025 → Oct 2030 expected postmenopausal osteoporosis University Hospital, Toulouse Recruiting No outcome recorded
Phase 4 NCT05743179 Dec 2022 → May 2025 pneumonia The University of Hong Kong Unknown No outcome recorded
Phase 4 NCT05091099 Jan 2022 → Nov 2025 osteoporosis National Taiwan University Hospital Completed No outcome recorded
Phase not applicable3 trials
— NCT01623908 Jul 2011 → Jun 2013 breast cancer, osteoporosis First Affiliated Hospital, Sun Yat-Sen University Terminated No outcome recorded
— NCT01205646 Sep 2010 → Aug 2013 prostate cancer Barbara Ann Karmanos Cancer Institute Completed No outcome recorded
— NCT00302484 Apr 2002 → ? osteoporosis Medical University of Vienna Unknown No outcome recorded
Comparator or background therapy10 trials
Phase 1 NCT05400603 Background Nov 2023 → Dec 2026 expected neuroblastoma, osteosarcoma Emory University Recruiting No outcome recorded
Phase 2 NCT00213980 Comparator Jan 2000 → Apr 2008 breast cancer University of Wisconsin, Madison Completed No outcome recorded
Phase 3 NCT05638399 Comparator Jan 2020 → Feb 2023 spondylolisthesis Shenzhen People's Hospital Unknown No outcome recorded
Phase 3 NCT02739594 Comparator Feb 2006 → Apr 2009 plasma cell myeloma Hoffmann-La Roche Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT07281586 Background Jan 2026 → Dec 2028 expected osteoporosis National Taiwan University Hospital Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2018-01-09 Axsome Therapeutics, Inc. Results Axsome Therapeutics Announces AXS-02 Independent Data Monitoring Committee Recommends Continuation of COAST-1 Trial and Discontinuation of CREATE-1 Trial gcs-web.com ↗
In the CREATE-1 trial, AXS-02 treatment resulted in a significant reduction of serum CTx, a marker of bone resorption, as compared to placebo (p<0.0001).

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 26 sources stand behind the page.

FieldValueCited text
Known as zoledronate “Investigator propose an open-label randomized superiority strategy trial to compare the 1-year lumbar densitometric efficacy of biomarkers-driven zoledronate (ZOL) infusion vs...” NCT06767150 ↗
25

“Zoledronate” NCT04549207 ↗

NCT07281586 ↗

NCT02739594 ↗

NCT02721433 ↗

NCT00301886 ↗

NCT05091099 ↗

NCT05638399 ↗

NCT02347163 ↗

NCT00102908 ↗

NCT02504008 ↗

Show 15 more sources

Known as AXS-02 “AXS-02 (oral zoledronate)” NCT02504008 ↗
Known as zol “zoledronate (zol)” NCT03358017 ↗
1

NCT06767150 ↗

Action Inhibit “BPs are mevalonate pathway inhibitors” NCT02347163 ↗
Modality Other / unclassified “an investigational bisphosphonate” NCT00102908 ↗
Route Intravenous “single IV dose of zoledronate” NCT00102908 ↗