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ALC-2203-2

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

ALC-2203-2 is a GPR84 agonist Small molecule drug developed by Korea Arlico Pharm. Co., Ltd. It is currently in Phase 2 development for Treatment of inflammatory diseases.

ALC-2203-2 is a selective and potent agonist of the GPR84 receptor.

ALC-2203-2 is a selective and potent agonist of the GPR84 receptor. Used for Treatment of inflammatory diseases.

Likelihood of approval
16.3% 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).
  • Immunology slight uplift +1.0pp
    Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
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 nameALC-2203-2
SponsorKorea Arlico Pharm. Co., Ltd
Drug classGPR84 agonist
TargetGPR84
ModalitySmall molecule
Therapeutic areaInflammation
PhasePhase 2

Mechanism of action

GPR84 is a G protein-coupled receptor that plays a role in the regulation of inflammation and immune responses. Activation of GPR84 by ALC-2203-2 may lead to anti-inflammatory effects and potential therapeutic benefits.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about ALC-2203-2

What is ALC-2203-2?

ALC-2203-2 is a GPR84 agonist drug developed by Korea Arlico Pharm. Co., Ltd, indicated for Treatment of inflammatory diseases.

How does ALC-2203-2 work?

ALC-2203-2 is a selective and potent agonist of the GPR84 receptor.

What is ALC-2203-2 used for?

ALC-2203-2 is indicated for Treatment of inflammatory diseases.

Who makes ALC-2203-2?

ALC-2203-2 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-2203-2 in?

ALC-2203-2 belongs to the GPR84 agonist class. See all GPR84 agonist drugs at /class/gpr84-agonist.

What development phase is ALC-2203-2 in?

ALC-2203-2 is in Phase 2.

What are the side effects of ALC-2203-2?

Common side effects of ALC-2203-2 include Nausea, Headache, Fatigue.

What does ALC-2203-2 target?

ALC-2203-2 targets GPR84 and is a GPR84 agonist.

Related

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