Last reviewed 2026-04-20 · How we verify

Ethidronate

Centre National d'Etudes Spatiales · Phase 1 active Small molecule Quality 7/100

Ethidronate is a Small molecule drug developed by Centre National d'Etudes Spatiales. It is currently in Phase 1 development for Heterotopic ossification, Humoral hypercalcemia of malignancy, Osteitis deformans.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	Ethidronate
Sponsor	Centre National d'Etudes Spatiales
Target	Type IV secretion-like conjugative transfer relaxase protein TraI
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

Heterotopic ossification
Humoral hypercalcemia of malignancy
Osteitis deformans

Common side effects

No common side effects on file.

Key clinical trials

Simulation of a Mission Aboard the International Space Station by a Long Duration Anti-Orthostatic Bed Confinement at - 6° (90 Days) on Healthy Subjects:1/Perfecting of Preventive Methods (Muscular Ex (Phase 1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

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

Ethidronate CI brief — competitive landscape report
Ethidronate updates RSS · CI watch RSS
Centre National d'Etudes Spatiales portfolio CI

Frequently asked questions about Ethidronate

What is Ethidronate?

Ethidronate is a Small molecule drug developed by Centre National d'Etudes Spatiales, indicated for Heterotopic ossification, Humoral hypercalcemia of malignancy, Osteitis deformans.

What is Ethidronate used for?

Ethidronate is indicated for Heterotopic ossification, Humoral hypercalcemia of malignancy, Osteitis deformans.

Who makes Ethidronate?

Ethidronate is developed by Centre National d'Etudes Spatiales (see full Centre National d'Etudes Spatiales pipeline at /company/centre-national-d-etudes-spatiales).

What development phase is Ethidronate in?

Ethidronate is in Phase 1.

What does Ethidronate target?

Ethidronate targets Type IV secretion-like conjugative transfer relaxase protein TraI.

Target: All drugs targeting Type IV secretion-like conjugative transfer relaxase protein TraI
Manufacturer: Centre National d'Etudes Spatiales — full pipeline
Therapeutic area: All drugs in Other
Indication: Drugs for Heterotopic ossification
Indication: Drugs for Humoral hypercalcemia of malignancy
Indication: Drugs for Osteitis deformans

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