Last reviewed 2026-04-19 · How we verify

BUTEDRONIC ACID

Phase 2 active Small molecule

BUTEDRONIC ACID is a butedronic acid drug. It is currently in Phase 2 development for Osteoporosis.

Butedronic acid works by inhibiting osteoclast activity, which are cells responsible for breaking down bone tissue.

Butedronic acid is a small molecule drug in the butedronic acid class, originally developed by an unknown entity and currently owned by an unknown entity. It is used to treat osteoporosis, a condition characterized by weakened bones. The exact mechanism of action is not specified, but it is believed to work by inhibiting bone resorption. The commercial status of butedronic acid is unclear, and it may be patented or available as a generic medication. Key safety considerations include unknown side effects and interactions.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	BUTEDRONIC ACID
Drug class	butedronic acid
Modality	Small molecule
Therapeutic area	Bone
Phase	Phase 2

Mechanism of action

Think of osteoclasts like demolition crews that break down old buildings. Butedronic acid is like a construction worker that stops the demolition crew from doing their job, allowing the bone to stay stronger. This helps to slow down bone loss and reduce the risk of fractures.

Approved indications

Osteoporosis

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

BUTEDRONIC ACID CI brief — competitive landscape report
BUTEDRONIC ACID updates RSS · CI watch RSS

Frequently asked questions about BUTEDRONIC ACID

What is BUTEDRONIC ACID?

BUTEDRONIC ACID is a butedronic acid drug, indicated for Osteoporosis.

How does BUTEDRONIC ACID work?

Butedronic acid works by inhibiting osteoclast activity, which are cells responsible for breaking down bone tissue.

What is BUTEDRONIC ACID used for?

BUTEDRONIC ACID is indicated for Osteoporosis.

What drug class is BUTEDRONIC ACID in?

BUTEDRONIC ACID belongs to the butedronic acid class. See all butedronic acid drugs at /class/butedronic-acid.

What development phase is BUTEDRONIC ACID in?

BUTEDRONIC ACID is in Phase 2.

Drug class: All butedronic acid drugs
Therapeutic area: All drugs in Bone
Indication: Drugs for Osteoporosis

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing