Last reviewed 2026-04-23 · How we verify

ALC-2203-AC

Korea Arlico Pharm. Co., Ltd · Phase 2 active Small molecule

ALC-2203-AC is a Kappa opioid receptor agonist Small molecule drug developed by Korea Arlico Pharm. Co., Ltd. It is currently in Phase 2 development for Chronic pain.

ALC-2203-AC is a selective and potent agonist of the kappa opioid receptor.

ALC-2203-AC is a selective and potent agonist of the kappa opioid receptor. Used for Chronic pain.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	ALC-2203-AC
Sponsor	Korea Arlico Pharm. Co., Ltd
Drug class	Kappa opioid receptor agonist
Target	Kappa opioid receptor
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Activation of the kappa opioid receptor is thought to produce analgesia with a lower risk of respiratory depression compared to mu opioid receptor agonists. This receptor is also implicated in the regulation of stress and anxiety responses.

Approved indications

Chronic pain

Common side effects

Nausea
Dizziness
Headache

Key clinical trials

To Evaluate the Efficacy and Safety of ALC-2203 in Patients With Acute Bronchitis (PHASE2)

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:

ALC-2203-AC CI brief — competitive landscape report
ALC-2203-AC updates RSS · CI watch RSS
Korea Arlico Pharm. Co., Ltd portfolio CI

Frequently asked questions about ALC-2203-AC

What is ALC-2203-AC?

ALC-2203-AC is a Kappa opioid receptor agonist drug developed by Korea Arlico Pharm. Co., Ltd, indicated for Chronic pain.

How does ALC-2203-AC work?

ALC-2203-AC is a selective and potent agonist of the kappa opioid receptor.

What is ALC-2203-AC used for?

ALC-2203-AC is indicated for Chronic pain.

Who makes ALC-2203-AC?

ALC-2203-AC is developed by Korea Arlico Pharm. Co., Ltd (see full Korea Arlico Pharm. Co., Ltd pipeline at /company/korea-arlico-pharm-co-ltd).

What drug class is ALC-2203-AC in?

ALC-2203-AC belongs to the Kappa opioid receptor agonist class. See all Kappa opioid receptor agonist drugs at /class/kappa-opioid-receptor-agonist.

What development phase is ALC-2203-AC in?

ALC-2203-AC is in Phase 2.

What are the side effects of ALC-2203-AC?

Common side effects of ALC-2203-AC include Nausea, Dizziness, Headache.

What does ALC-2203-AC target?

ALC-2203-AC targets Kappa opioid receptor and is a Kappa opioid receptor agonist.

Drug class: All Kappa opioid receptor agonist drugs
Target: All drugs targeting Kappa opioid receptor
Manufacturer: Korea Arlico Pharm. Co., Ltd — full pipeline
Therapeutic area: All drugs in Pain
Indication: Drugs for Chronic pain

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