Last reviewed 2026-04-20 · How we verify

IN-C004 without water

HK inno.N Corporation · Phase 1 active Small molecule Quality 3/100

IN-C004 without water is a Small molecule drug developed by HK inno.N Corporation. It is currently in Phase 1 development. Also known as: IN-C004.

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	IN-C004 without water
Also known as	IN-C004
Sponsor	HK inno.N Corporation
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 to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy 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:

IN-C004 without water CI brief — competitive landscape report
IN-C004 without water updates RSS · CI watch RSS
HK inno.N Corporation portfolio CI

Frequently asked questions about IN-C004 without water

What is IN-C004 without water?

IN-C004 without water is a Small molecule drug developed by HK inno.N Corporation.

Who makes IN-C004 without water?

IN-C004 without water is developed by HK inno.N Corporation (see full HK inno.N Corporation pipeline at /company/hk-inno-n-corporation).

Is IN-C004 without water also known as anything else?

IN-C004 without water is also known as IN-C004.

What development phase is IN-C004 without water in?

IN-C004 without water is in Phase 1.

Manufacturer: HK inno.N Corporation — full pipeline
Also known as: IN-C004

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