Last reviewed 2026-05-31 · How we verify

Vamifeport PR1

CSL Behring · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

Vamifeport PR1 is a Small molecule drug developed by CSL Behring. It is currently in Phase 1 development. Also known as: CSL624.

Vamifeport PR1 is a small molecule, as classified by ChEMBL. It is being studied in a Phase 1 clinical trial (NCT06726863) to characterize its pharmacokinetics, pharmacodynamics, and safety in healthy adults.

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	Vamifeport PR1
Also known as	CSL624
Sponsor	CSL Behring
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Pharmacokinetics and Pharmacodynamics of Two Prolonged-release Formulations of Vamifeport in Healthy Adults (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:

Vamifeport PR1 CI brief — competitive landscape report
Vamifeport PR1 updates RSS · CI watch RSS
CSL Behring portfolio CI

Frequently asked questions about Vamifeport PR1

What is Vamifeport PR1?

Vamifeport PR1 is a Small molecule drug developed by CSL Behring.

Who makes Vamifeport PR1?

Vamifeport PR1 is developed by CSL Behring (see full CSL Behring pipeline at /company/csl-behring).

Is Vamifeport PR1 also known as anything else?

Vamifeport PR1 is also known as CSL624.

What development phase is Vamifeport PR1 in?

Vamifeport PR1 is in Phase 1.

Manufacturer: CSL Behring — full pipeline
Also known as: CSL624

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