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Pharma & CDMOKOSDAQ 14502017 approvals11 trials

Hugel is a KOSDAQ-listed pharmaceutical/CDMO company making a botulinum toxin injectable and the hyaluronic acid filler The Chaeum.

As of 2026-10-10, Hugel, Inc. has 11 Korean MFDS device approvals, 5 Korean MFDS drug approvals, 1 US FDA clearance/approval, 20 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Business overview

Source: DART corporate disclosure

Founded in November 2001 and listed on KOSDAQ in December 2015, Hugel is a pharmaceutical and CDMO company. It makes a botulinum toxin injectable line and hyaluronic acid fillers 'The Chaeum' and 'The Chaeum Premium'. The toxin line spans five dosage forms (50-300 units), MFDS-approved 2010-2021, used for wrinkles, blepharospasm, post-stroke spasticity, and pediatric cerebral palsy deformity.

Products & technology

  • 보툴렉스Glabellar and periorbital wrinkles for aesthetic use; also blepharospasm, post-stroke upper limb spasticity, and pediatric cerebral palsy equinus deformity
  • The ChaeumHyaluronic acid (HA) filler for wrinkle management and facial contouring
  • 더채움 프리미엄Lidocaine-added hyaluronic acid filler to reduce procedural pain

Regulatory approvals

data.go.kr · openFDA

5 Korean MFDS drug approvals · 2009–2021 / 11 Korean MFDS device approvals · 2002–2017 / 1 US FDA drug approvals · 2024

  • FDA drugLETYBO2024-02-29
    FDA drug approval · BLABLA761225
  • MFDS drugBotulax®300 unit2021-01-28
    Drug · Prescription · Approval202100911
  • MFDSDilator, balloonRevoked2017-12-28
    Product approval · Class 2수인 17-4827 호
  • MFDS drugBotulax®150 unit2016-04-29
    Drug · Prescription · Approval201602416
  • MFDSGraft/prosthesis, biomaterialRevoked2011-11-21
    Product approval · Class 4제허 11-1266 호
  • MFDSGraft/prosthesis, biomaterialRevoked2011-11-21
    Product approval · Class 4제허 11-1268 호
  • MFDSGraft/prosthesis, biomaterialRevoked2011-11-21
    Product approval · Class 4제허 11-1270 호
  • MFDS drugBotulax®50 unit2011-10-12
    Drug · Prescription · Approval201108443
  • MFDSEmbolization implant inserter, cerebrovascularRevoked2010-11-02
    Product approval · Class 4수허 10-1146 호
  • MFDS drugBotulax®200 unit2010-02-03
    Drug · Prescription · Approval201001176
  • MFDS혈관내튜브·카테터Revoked2009-05-26
    Product approval · Class 2수허 09-503 호
  • MFDS drugBotulax® (Clostridium Botulinum Toxin A type)2009-03-13
    Drug · Prescription · Approval200901953
Show 5 more
  • MFDS흡인용튜브·카테터Revoked2008-11-20
    Product approval · Class 1서울 수신 08-2019 호
  • MFDS의료용흡인기Revoked2008-10-06
    Product approval · Class 2수허 08-957 호
  • MFDSEmbolization implant inserter, cerebrovascularRevoked2007-08-29
    Product approval · Class 4수허 07-754 호
  • MFDSEmbolization implant inserter, cerebrovascularRevoked2003-03-05
    Product approval · Class 4수허 03-301 호
  • MFDSEmbolization implant inserter, cerebrovascularRevoked2002-08-14
    Product approval · Class 4수허 02-898 호

Clinical trials

data.go.kr

11 MFDS clinical trial authorisations · 2013–2026 (Phase 1 4 · Phase 3 2 · Phase 2b 1 · Phase 0 1 · Phase 2 1)

  • Phase 2b보툴렉스주(클로스트리디움보툴리눔독소A형)2026-09-23

    2 trial sites

  • Phase 3HG1022023-06-12

    4 trial sites

  • Phase 0보툴렉스주2022-12-09

    1 trial site

  • Phase 1HG1022021-01-27

    1 trial site

  • Phase 2보툴렉스주(클로스트리디움보툴리눔독소A형)2019-08-27

    2 trial sites

  • Phase 1보툴렉스주(클로스트리디움보툴리눔독소A형)2019-02-27

    3 trial sites

  • Phase 2aBMT1012018-11-07

    10 trial sites

  • Phase 1보툴렉스주(클로스트리디움보툴리눔독소A형)2018-09-12

    6 trial sites

  • Phase 1/3보툴렉스주(클로스트리디움보툴리눔독소A형)2017-09-11

    3 trial sites

  • Phase 1BMT1012017-01-23

    1 trial site

  • Phase 3보툴렉스주(클로스트리디움보툴리눔독소A형)2013-06-13

    6 trial sites

Global clinical trials

ClinicalTrials.gov · sponsor-matched
Show 8 more trials

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched
Show 10 more publications

Patents

KIPRIS · applicant-matched
Show 106 more patents

AI reads

MAA server logs · IP-verified
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Measured since Aug 26, 2026 · 5 AI engines · last read Oct 9, 2026

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Companies approved for the same productsPharma & CDMO

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

SEWOONMEDICAL CO,. LTD.3 shared

Founded in 1982 and KOSDAQ-listed in 2008, Sewoon Medical manufactures medical aspirators and catheters/tubes.

L&C BIO Co., Ltd2 shared

L&C BIO manufactures human tissue grafts across 11 tissue types, including the acellular dermal matrix MegaDerm, plus tissue-based medical devices.

SHINHUNG CO.,LTD2 shared

Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.

DongBang Medical Co., Ltd.2 shared

KOSDAQ-listed medical device maker producing disposable acupuncture needles, cupping cups, and hyaluronic acid dermal fillers.

GC Medical Science Corporation2 shared

GC Medical Science Corporation, KOSDAQ-listed since 2014, operates diagnostic reagent, blood glucose, and hemodialysis solution businesses.

PharmaResearch Co., Ltd.2 shared

KOSDAQ-listed medical device company producing PDRN pharmaceuticals, HA fillers, and Rejuran-branded cosmetics.

Alpha AI Co.,Ltd.2 shared

Alpha AI, founded in 1995 and KOSDAQ-listed in 2000, manufactures biocompatible metal implants and surgical instruments.

DONG-A ST CO.,LTD2 shared

Dong-A ST, spun off from Dong-A Socio Holdings in 2013 and KOSPI-listed, makes prescription drugs like Growtropin, Stillen, and Bacchus.

WonIk Co.,LTD1 shared

WonIk, founded in 1983 and KOSDAQ-listed in 1997, operates pressure sensor, dermo-cosmetic, and medical device distribution businesses.

Autech Corporation1 shared

Founded in 1991 and KOSDAQ-listed in 2003, Autech Corporation manufactures specialty vehicles such as ambulances and refrigerated trucks.

Medy-Tox Inc.1 shared

Founded 2000, KOSDAQ-listed 2009, Medy-Tox develops and exports botulinum toxin biopharmaceuticals including Meditoxin and Innotox.

MITECH CO.,LTD.1 shared

MITECH CO.,LTD., founded in 1991 and listed on KOSDAQ in 2018, makes non-vascular stents and distributes Fujifilm endoscopy equipment.

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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