Last reviewed 2026-05-27 · How we verify

Xerecept 1.0

Celtic Pharma Development Services · Phase 1 active Small molecule ✓ Verified May 2026

Xerecept 1.0 is a Small molecule drug developed by Celtic Pharma Development Services. It is currently in Phase 1 development. Also known as: hCRF infusion, 1.0 ug/kg/hr.

Xerecept 1.0 is a medication used to treat edema, as indicated by ClinicalTrials.gov. The exact mechanism of action of Xerecept 1.0 is not specified in the provided facts, but it is being studied in a Phase 1 dose escalation trial to compare its safety, tolerability, pharmacokinetic, and pharmacodynamic profiles.

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	Xerecept 1.0
Also known as	hCRF infusion, 1.0 ug/kg/hr
Sponsor	Celtic Pharma Development Services
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers (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:

Xerecept 1.0 CI brief — competitive landscape report
Xerecept 1.0 updates RSS · CI watch RSS
Celtic Pharma Development Services portfolio CI

Frequently asked questions about Xerecept 1.0

What is Xerecept 1.0?

Xerecept 1.0 is a Small molecule drug developed by Celtic Pharma Development Services.

Who makes Xerecept 1.0?

Xerecept 1.0 is developed by Celtic Pharma Development Services (see full Celtic Pharma Development Services pipeline at /company/celtic-pharma-development-services).

Is Xerecept 1.0 also known as anything else?

Xerecept 1.0 is also known as hCRF infusion, 1.0 ug/kg/hr.

What development phase is Xerecept 1.0 in?

Xerecept 1.0 is in Phase 1.

Manufacturer: Celtic Pharma Development Services — full pipeline
Also known as: hCRF infusion, 1.0 ug/kg/hr

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