Last reviewed 2026-06-01 · How we verify

HC-5404-FU

HiberCell, Inc. · Phase 1 active Small molecule ✓ Verified Jun 2026

HC-5404-FU is a Small molecule drug developed by HiberCell, Inc.. It is currently in Phase 1 development. Also known as: HC-5404.

HC-5404-FU is a small molecule being studied in a Phase 1a clinical trial for its safety and maximum tolerated dose in patients with advanced solid tumors, including Renal Cell Carcinoma, Gastric Cancer, Metastatic Breast Cancer, Small-cell Lung Cancer, and Other Solid Tumors. The study aims to establish the maximum tolerated dose of HC-5404-FU in this patient population.

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	HC-5404-FU
Also known as	HC-5404
Sponsor	HiberCell, Inc.
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 of HC-5404-FU to Establish the Maximum Tolerated Dose (MTD) (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:

HC-5404-FU CI brief — competitive landscape report
HC-5404-FU updates RSS · CI watch RSS
HiberCell, Inc. portfolio CI

Frequently asked questions about HC-5404-FU

What is HC-5404-FU?

HC-5404-FU is a Small molecule drug developed by HiberCell, Inc..

Who makes HC-5404-FU?

HC-5404-FU is developed by HiberCell, Inc. (see full HiberCell, Inc. pipeline at /company/hibercell-inc).

Is HC-5404-FU also known as anything else?

HC-5404-FU is also known as HC-5404.

What development phase is HC-5404-FU in?

HC-5404-FU is in Phase 1.

Manufacturer: HiberCell, Inc. — full pipeline
Also known as: HC-5404

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