Last reviewed 2026-06-03 · How we verify

ASP1707 single dose fasted

Astellas Pharma Europe B.V. · Phase 1 active Small molecule ✓ Verified Jun 2026 Quality 0/100

ASP1707 single dose fasted is a Small molecule drug developed by Astellas Pharma Europe B.V.. It is currently in Phase 1 development.

ASP1707 is a substance that has been studied in a clinical trial (NCT02368912) for its pharmacokinetics and pharmacodynamics. The trial involved administering a single dose of ASP1707 to healthy subjects in a fasted state.

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	ASP1707 single dose fasted
Sponsor	Astellas Pharma Europe B.V.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Assess the Safety, Tolerability and Effects of Single and Multiple Ascending Doses of ASP1707 in Healthy Male and Pre-menopausal Female Subjects, Including a Comparison of the Effects Under Fasted and Fed Conditions in Healthy Young Male Subjects (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:

ASP1707 single dose fasted CI brief — competitive landscape report
ASP1707 single dose fasted updates RSS · CI watch RSS
Astellas Pharma Europe B.V. portfolio CI

Frequently asked questions about ASP1707 single dose fasted

What is ASP1707 single dose fasted?

ASP1707 single dose fasted is a Small molecule drug developed by Astellas Pharma Europe B.V..

Who makes ASP1707 single dose fasted?

ASP1707 single dose fasted is developed by Astellas Pharma Europe B.V. (see full Astellas Pharma Europe B.V. pipeline at /company/astellas-pharma-europe-b-v).

What development phase is ASP1707 single dose fasted in?

ASP1707 single dose fasted is in Phase 1.

Manufacturer: Astellas Pharma Europe B.V. — full pipeline

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