Organization (Industry)
Huons (South Korea)
ClinicalTrials.gov lists Huons (South Korea) as lead sponsor of 29 trials. It has 20 active development programs and 7 approved assets.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 5 registered with a 2026 start date. The dashed outline is the pace from the 4 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 2.4 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Huons (South Korea): 29 lead-sponsored trials and 1 legal-entity registration.
Disease areas (14)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Dry Eye Syndromes | 8 |
| Hypertension | 3 |
| Diabetes Mellitus | 2 |
| Bone Diseases, Metabolic | 1 |
| Fatty Liver | 1 |
Showing 5 of 14 disease areas.
Trials by start year as sponsor or collaborator (10)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 5 |
| 2024 | 5 |
| 2023 | 1 |
| 2022 | 2 |
| 2019 | 3 |
| 2018 | 4 |
| 2017 | 1 |
| 2016 | 4 |
| 2014 | 2 |
| 2013 | 2 |
Recruitment duration, a model prediction: 1 trial still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (20)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| HUC3-637-R | Glaucoma, Open-Angle | Phase 3 | 1 |
| HUC3-637-R | Glaucoma | Phase 3 | 1 |
| HUC3-637 | Glaucoma | Phase 3 | 1 |
| HUC3-637 | Glaucoma, Open-Angle | Phase 3 | 1 |
| HU007 | Dry Eye Syndromes | Phase 3 | 4 |
Showing 5 of 20 active programs.
Approved assets (7)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| 2% lidocaine HCl with epinephrine 1:200,000 | 1 |
| 2% lidocaine HCl with epinephrine 1:80,000 | 1 |
| CYCLOSPORINE | 4 |
| BOTULINUM TOXIN TYPE-A | 1 |
| ATORVASTATIN | 1 |
Showing 5 of 7 approved assets.
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 80% hit target (n=5) | 60% on time (n=5) |
Journals published in (1)
| Journal | Publications |
|---|---|
| Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics | 1 |
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 4 | 0 | 2020-04-28 |
FDA warning letters (1)
| Issue date | Letter |
|---|---|
| 2026-06-15 | huons-co-ltd-724650-06152026 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 6 |
FDA recalls (4)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton) | Class II | 2026-04-02 |
| Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules) | Class II | 2026-04-02 |
| 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1. | Class II | 2026-04-02 |
| Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton) | Class II | 2026-04-02 |
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 16 | 2026-06-24 |
Manufacturing and distribution sites (2)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| HUONS CO., LTD. | Jecheon-si Chungbuk, KR | FDA, Health Canada | |
| Huons Co., Ltd. | Jecheon-si, KR | FDA |
Latest dated events (60)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-10 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-09 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-07 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-06-24 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-06-15 | FDA warning letter | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
Showing 5 of 60 events.
Biomarker capability evidence (6)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| CFL1 | Trial sponsor | Named in trial inclusion criteria |
| GLB1 | Trial sponsor | Named in trial exclusion criteria |
| GLB1 | Trial sponsor | Named in trial exclusion criteria |
| CFL1 | Trial sponsor | Mentioned in trial text |
| GLB1 | Trial sponsor | Mentioned in trial text |
Showing 5 of 6 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, sec-reported annual financials, financing and grant events, fda untitled letters, climate targets, as filed, workforce and board diversity, as filed, organization relationships, clia clinical laboratory certificates, and biomarkers this organization publishes on.