Who are AXS-02 (oral zoledronate)'s main competitors?

Direct comparators (same drug class / molecular target / therapeutic area): Boniva, Zometa, Fosamax, Aredia, Alendronate (ALN), Effervescent and buffered alendronate.

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Last reviewed 2026-05-18 · How we verify

AXS-02 (oral zoledronate) — Competitive Intelligence Brief

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

AXS-02 (oral zoledronate) (AXS-02 (oral zoledronate)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Bisphosphonate. Area: Bone metabolism / Oncology.

phase 3 Bisphosphonate Farnesyl pyrophosphate synthase Bone metabolism / Oncology Small molecule Live · refreshed every 30 min

Target snapshot

AXS-02 (oral zoledronate) (AXS-02 (oral zoledronate)) — Axsome Therapeutics, Inc.. AXS-02 is an oral formulation of zoledronate, a bisphosphonate that inhibits osteoclast-mediated bone resorption by blocking farnesyl pyrophosphate synthase in the mevalonate pathway.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
AXS-02 (oral zoledronate) TARGET	AXS-02 (oral zoledronate)	Axsome Therapeutics, Inc.	phase 3	Bisphosphonate	Farnesyl pyrophosphate synthase
Boniva	IBANDRONIC ACID	Hoffmann La Roche	marketed	Bisphosphonate	Farnesyl pyrophosphate synthase	2003-01-01
Zometa	ZOLEDRONIC ACID	Novartis	marketed	zoledronic acid	Farnesyl pyrophosphate synthase	2001-01-01
Fosamax	ALENDRONIC ACID	Merck And Co Inc	marketed	Vitamin D [EPC]	Farnesyl pyrophosphate synthase	1995-01-01
Aredia	PAMIDRONIC ACID		marketed	Bisphosphonate	Farnesyl pyrophosphate synthase	1991-01-01
Alendronate (ALN)	Alendronate (ALN)	Chinese University of Hong Kong	marketed	Bisphosphonate	Farnesyl pyrophosphate synthase (FPPS); hydroxyapatite
Effervescent and buffered alendronate	Effervescent and buffered alendronate	Aarhus University Hospital	marketed	Bisphosphonate	Farnesyl pyrophosphate synthase; hydroxyapatite in bone

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

2031-12-05 — Fosamax · 9592195 · US

Sponsor landscape (Bisphosphonate class)

· 2 drugs in this class
Amgen · 2 drugs in this class
National Taiwan University Hospital · 2 drugs in this class
Sanofi · 2 drugs in this class
Ludwig-Maximilians - University of Munich · 2 drugs in this class
Chinese University of Hong Kong · 1 drug in this class
Chinese Society of Lung Cancer · 1 drug in this class
Aarhus University Hospital · 1 drug in this class
Eisai Inc. · 1 drug in this class
Daiichi Sankyo Co., Ltd. · 1 drug in this class

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Cite this brief

Drug Landscape (2026). AXS-02 (oral zoledronate) — Competitive Intelligence Brief. https://druglandscape.com/ci/axs-02-oral-zoledronate. Accessed 2026-05-18.

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