Last reviewed 2026-05-31 · How we verify

Calcium Levofolinate Hydrateb

Ono Pharmaceutical Co. Ltd · Phase 1 active Small molecule ✓ Verified May 2026

Calcium Levofolinate Hydrateb is a Small molecule drug developed by Ono Pharmaceutical Co. Ltd. It is currently in Phase 1 development. Also known as: ISOVORIN.

Calcium Levofolinate Hydrate is a small molecule with an unknown mechanism of action. It is being studied in clinical trials for the treatment of colorectal cancer, often in combination with other medications such as ONO-4578, ONO-4538, and Capecitabine.

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	Calcium Levofolinate Hydrateb
Also known as	ISOVORIN
Sponsor	Ono Pharmaceutical Co. Ltd
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer (PHASE1)

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:

Calcium Levofolinate Hydrateb CI brief — competitive landscape report
Calcium Levofolinate Hydrateb updates RSS · CI watch RSS
Ono Pharmaceutical Co. Ltd portfolio CI

Frequently asked questions about Calcium Levofolinate Hydrateb

What is Calcium Levofolinate Hydrateb?

Calcium Levofolinate Hydrateb is a Small molecule drug developed by Ono Pharmaceutical Co. Ltd.

Who makes Calcium Levofolinate Hydrateb?

Calcium Levofolinate Hydrateb is developed by Ono Pharmaceutical Co. Ltd (see full Ono Pharmaceutical Co. Ltd pipeline at /company/ono-pharmaceutical-co-ltd).

Is Calcium Levofolinate Hydrateb also known as anything else?

Calcium Levofolinate Hydrateb is also known as ISOVORIN.

What development phase is Calcium Levofolinate Hydrateb in?

Calcium Levofolinate Hydrateb is in Phase 1.

Manufacturer: Ono Pharmaceutical Co. Ltd — full pipeline
Also known as: ISOVORIN

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