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DAEWOONG THERAPEUTICS

Platform 01

CLOPAM®

Closed-Packed Aero-Pressurized Microneedle

Dissolving microneedle patch

A proprietary dissolving microneedle array patch (DMAP) platform, optimized for systemic and local drug delivery.

Test CLOPAM with your molecule How it works

CLOPAM for your program

World-first fully aseptic patch GMP · in operation since 3Q 2026

Peptides · Hormones · Vaccines · Small molecules · mRNA

  • ~80%

    Bioavailability

    Of the SC injection, proven in humans with a high-molecular-weight peptide — exceptionally high for a patch.

  • Tip-loaded

    Precision dosing

    Patented aero-pressure drying concentrates the drug in the needle tips.

  • In-mold

    Product integrity

    Every needle stays aseptic in its own sealed mold until use.

  • Aseptic GMP Ready

    Sterile drug product

    The U.S. FDA regards this patch as a sterile drug product — and ours is made on fully aseptic GMP lines.

01 — The problem

What CLOPAM solves

Where today's delivery falls short — for patients, for the drugs themselves, and for the microneedle patches that tried to fix it.

For patients

For drugs

For microneedles

02 — The CLOPAM difference

The bottleneck, broken.

Dissolving microneedles have worked in the lab for years. Getting every needle to the patient sterile and intact is what kept them from becoming products.

Every needle aseptic, from plant to patient

Other dissolving microneedle patches

  • Pulled out of the silicone mold and moved into blister packaging
  • Needles exposed to contaminants, humidity and physical force in storage and transport
  • Tips bend, soften or break, and sterility is hard to hold

CLOPAM

  • Stays in its own disposable mold until the patient applies it
  • Hermetically sealed against contaminants, moisture and force
  • Every single needle reaches the skin aseptic and intact

Keeping each needle aseptic through storage and distribution is the bottleneck that has kept dissolving microneedles from commercial products. CLOPAM solves it by design.

Drug concentrated at the tips

Our patented aero-pressure drying drives the drug into the needle tips. The tips are what enter the skin, so more of the dose is delivered and less is left behind in the backing.

  • Optimal penetration depth
  • No injection pain
  • Consistent, uniform application
Real image · human cadaver skinFluorescence image of human cadaver skin after a CLOPAM patch: the drug, in green, sits at the tips of the needle tracks below the skin surface
Fluorescence imaging in human cadaver skin. Dotted outlines: needle tracks; green: the delivered drug.

03 — How it works

CLOPAM, step by step

  1. Step 01

    Apply

    The applicator lifts the patch straight out of its sealed mold and presses it onto the skin; an audible click confirms it.

  2. Step 02

    Dissolve

    The microneedles dissolve quickly in the skin's interstitial fluid.

  3. Step 03

    Release

    The drug, concentrated in the needle tips by aero-pressure drying, is released into the skin.

  4. Step 04

    Absorb

    It acts locally in the skin or is absorbed into systemic circulation, depending on the payload.

CLOPAM dissolving microneedle patchCLOPAM applicator pressed onto the skin with an audible click

CLOPAM patch & applicator

  • Precision dosing: patented aero-pressure drying concentrates the drug in the needle tips.
  • Aerodynamic crafting controls how the needles form and are handled.
  • Each patch stays in its own sealed mold, so every needle is aseptic and intact until use.
  • Patented applicator: vertical extraction of the needles from the mold and consistent force on application, confirmed by an audible click.
  • Can be applied to the forearm, upper arm or back.

04 — Proof of concept

Proven in people: ~80% of SC bioavailability

In pilot PK studies in healthy volunteers, the CLOPAM patch delivered a high-molecular-weight peptide at about 80% of the bioavailability of its SC injection — consistent across studies and dose levels, with dose-linear exposure and almost no skin irritation.

~80%

Relative bioavailability vs SC injection

Dose-normalized, with a high-molecular-weight peptide in healthy volunteers. Consistent across pilot PK studies and patch doses.

In human · pilot PK studies, patch vs SC injection

Healthy volunteers received a high-molecular-weight peptide as the CLOPAM patch or as the marketed SC injection. Patch doses are higher than the SC dose, so bioavailability is compared dose-normalized.

SC injection (marketed product)CLOPAM patch

  • Plasma concentration

    2nd pilot study

    SC 0.5 mg against a 2.0 mg patch

    Time →Plasma conc. (log) →
    Dose · SC : patch
    0.5 mg : 2.0 mg (1 : 4)
    Relative bioavailability
    88%

    Consistent across pilot studies

  • Dose linearity

    3rd pilot study

    SC 1.0 mg against three patch doses; fainter = lower dose

    Time →Plasma conc. (log) →
    Dose · SC
    1.0 mg
    Dose · patch
    0.5 · 1.0 · 2.0 mg
    Relative bioavailability
    83% · 85% · 82%

    Dose-linear · 3 dose levels

  • Skin irritation

    2nd pilot study

    Real images of the application site after the patch was worn for 2, 4 and 8 hours.

    Skin at the patch site after 2 hours of wear
    2 h wear
    Skin at the patch site after 4 hours of wear
    4 h wear
    Skin at the patch site after 8 hours of wear
    8 h wear

    Almost no skin irritation

    Severe or clinically significant irritation
    None reported

    Mild and transient

The peptide and the reference product are not named. Relative bioavailability is dose-normalized to the SC injection. Full datasets are shared with partners under CDA.

Request the data under CDA

05 — GMP manufacturing

The world's first fully aseptic microneedle patch plant

Since 3Q 2026, our Hyangnam plant has been making microneedle patches on fully automated, aseptic lines — to our knowledge, the first anywhere in the world. It takes CLOPAM from our lab-scale site, in operation since 2024, toward full commercial production in Osong by 2030.

Run with Daewoong Group's GMP and quality expertise — the group behind U.S. FDA cGMP manufacturing of biologics such as Nabota®.

World first

Fully aseptic GMP · in operation since

3Q 2026

Built for late-stage trials, clinical supply and initial commercial supply, with room to grow.

Planning a patch program? Production slots on the aseptic lines are limited — contact us to secure one.

Reserve a GMP slot
  1. Lab-scale manufacturing site in Yongin

    Phase 01 · Since 2024

    Lab scale

    Yongin, South Korea

    Process
    Microbial-limit controlled, semi-automated; passed MFDS GMP inspection
    Status
    In operation; Phase 1 clinical supply since 2024
  2. Fully aseptic microneedle patch plant in Hyangnam

    Phase 02 · Since 3Q 2026

    World first

    Pilot scale

    Hyangnam, South Korea

    Process
    Fully automated and aseptic, to global standards
    Status
    In operation since 3Q 2026
    Use
    Late-stage trials, clinical supply and initial commercial supply
  3. Planned commercial-scale facility in Osong

    Phase 03 · 2030

    Commercial scale

    Osong, South Korea · new facility

    Process
    Fully automated and aseptic, to global standards
    Status
    Planned, with budget and site secured; operational by 2030
    Use
    Full-scale commercial production

Real images

Inside the aseptic plant

  • Aseptic isolator line next to a sealed process chamber in the CLOPAM plant

    Isolator line and process chamber

  • Glove ports on an isolator window, with the robotic line behind, in the aseptic CLOPAM plant

    Glove ports: no open handling

  • Isolator workstation with glove ports and patch trays inside, in the aseptic CLOPAM plant

    Aseptic isolator workstation

06 — Compatible payloads

What you can bring

Bring any of these — we assess fit for your molecule in a feasibility study.

  • Peptides

    Obesity, MASH and endocrine peptides, kept on their weekly schedule as a patch.

    Phase 1 IND approvedSee the case

  • Hormones

    Protein hormones given by frequent injection, moved to a self-applied patch.

    IND approved

  • Vaccines

    Antigens placed among the skin's immune cells, aseptically, needle by needle.

    PreclinicalSee the case

  • Hard-to-deliver small molecules

    Hydrophilic or poorly absorbed drugs that creams, gels and pills cannot carry well.

    See the case

  • mRNA

    mRNA and other nucleic acids, delivered precisely into the skin's immune layer.

    See the case

07 — Partnering use cases

How partners use CLOPAM

01

Injectable → Patch

Reformulate an approved or clinical-stage injectable as a self-administered patch.

02

Weekly obesity & MASH peptides

Keep a GLP-1-class peptide on its once-weekly schedule — as a patch instead of an injection.

See the case

03

Large molecules, topically

Take drugs too large or hydrophilic for a gel, and too costly as a pill, into the skin.

See the case

04

New formulation co-development

Design a patch product around a new molecule from the start.

05

Life-cycle extension

A new, needle-free presentation of a marketed drug: new IP and a longer life.

08 — IP & readiness

Built to be partnered

Intellectual property
[TBD: CLOPAM patent status overview]
  • PatentedAero-pressure manufacturing that concentrates the drug in the needle tips
  • PatentedApplicator that lifts the patch vertically out of its mold and applies consistent force
Manufacturing readiness
Fully automated, aseptic GMP plant in Hyangnam, Korea, in operation since 3Q 2026, after a lab-scale site in operation since 2024; commercial scale in Osong by 2030.

Test CLOPAM with your molecule.

Share your molecule and goals. We'll propose a feasibility plan.
Contact our BD team
Our other platformThermicraUltra-high concentration formulation for subcutaneous injectionExplore Thermicra