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Umkamin(Active Comparator)

Hanlim Pharm. Co., Ltd. · Phase 3 active Small molecule Under review

Umkamin(Active Comparator) is a GLP-1 receptor agonist Small molecule drug developed by Hanlim Pharm. Co., Ltd.. It is currently in Phase 3 development for Type 2 diabetes. Also known as: Placebo of HL301 and Umkamin.

Umkamin is a glucagon-like peptide-1 (GLP-1) receptor agonist.

Umkamin is a small molecule used as an active comparator in a clinical trial for acute bronchitis. It is being compared to HL301 in a multicenter, randomized, double-blinded, active-controlled, parallel, Phase III clinical trial.

Likelihood of approval
58.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% 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 2028–2030
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +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 nameUmkamin(Active Comparator)
Also known asPlacebo of HL301 and Umkamin
SponsorHanlim Pharm. Co., Ltd.
Drug classGLP-1 receptor agonist
TargetGLP-1R
ModalitySmall molecule
Therapeutic areaDiabetes
PhasePhase 3

Mechanism of action

It works by mimicking the action of the natural hormone GLP-1, which increases insulin secretion and decreases glucagon levels, thereby lowering blood glucose levels.

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 Umkamin(Active Comparator)

What is Umkamin(Active Comparator)?

Umkamin(Active Comparator) is a GLP-1 receptor agonist drug developed by Hanlim Pharm. Co., Ltd., indicated for Type 2 diabetes.

How does Umkamin(Active Comparator) work?

Umkamin is a glucagon-like peptide-1 (GLP-1) receptor agonist.

What is Umkamin(Active Comparator) used for?

Umkamin(Active Comparator) is indicated for Type 2 diabetes.

Who makes Umkamin(Active Comparator)?

Umkamin(Active Comparator) is developed by Hanlim Pharm. Co., Ltd. (see full Hanlim Pharm. Co., Ltd. pipeline at /company/hanlim-pharm-co-ltd).

Is Umkamin(Active Comparator) also known as anything else?

Umkamin(Active Comparator) is also known as Placebo of HL301 and Umkamin.

What drug class is Umkamin(Active Comparator) in?

Umkamin(Active Comparator) belongs to the GLP-1 receptor agonist class. See all GLP-1 receptor agonist drugs at /class/glp-1-receptor-agonist.

What development phase is Umkamin(Active Comparator) in?

Umkamin(Active Comparator) is in Phase 3.

What are the side effects of Umkamin(Active Comparator)?

Common side effects of Umkamin(Active Comparator) include Nausea, Vomiting, Diarrhea.

What does Umkamin(Active Comparator) target?

Umkamin(Active Comparator) targets GLP-1R and is a GLP-1 receptor agonist.

Related

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