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NEWS #PharmaBuzz
22 Apr 2026
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-april-22-2026-72558.pdf
03 Apr 2026
// FDA
07 Nov 2024
// BUSINESSWIRE
23 Sep 2021
// Shim Hyun-tai KOREABIOMED
http://www.koreabiomed.com/news/articleView.html?idxno=12209
07 Jul 2021
// KOREAHERALD
Drugs in Development
Details:
Dorzolamide is a small molecule drug, which is currently being evaluated in Phase III clinical studies for the treatment of glaucoma, open-angle.
Lead Product(s): Dorzolamide Hydrochloride,Timolol Maleate
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 13, 2026
Lead Product(s) : Dorzolamide Hydrochloride,Timolol Maleate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Dorzolamide is a small molecule drug, which is currently being evaluated in Phase III clinical studies for the treatment of glaucoma, open-angle.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 13, 2026
Details:
HUC2-676 is a peptide drug, which is currently being evaluated in Phase I clinical studies for the treatment of obesity.
Lead Product(s): HUC2-676,HUC2-676-R
Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 13, 2026
Lead Product(s) : HUC2-676,HUC2-676-R
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : HUC2-676 is a peptide drug, which is currently being evaluated in Phase I clinical studies for the treatment of obesity.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
January 13, 2026
Details:
HUC2-565-A is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Hypertension.
Lead Product(s): HUC2-565-A,HUC2-565-B
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 01, 2024
Lead Product(s) : HUC2-565-A,HUC2-565-B
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Drug-Drug Interaction Study Between HUC2-565-A and HUC2-565-B
Details : HUC2-565-A is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Hypertension.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
October 01, 2024
Details:
HUC2-344 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Diabetes Mellitus.
Lead Product(s): HUC2-344,HUC2-344-R1,HUC2-344-R2
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 13, 2024
Lead Product(s) : HUC2-344,HUC2-344-R1,HUC2-344-R2
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Phase 1 Study in Diabetes Mellitus(Fed)
Details : HUC2-344 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Diabetes Mellitus.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 13, 2024
Details:
HUC2-344 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Diabetes Mellitus.
Lead Product(s): HUC2-344,HUC2-344-R1,HUC2-344-R2
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 13, 2024
Lead Product(s) : HUC2-344,HUC2-344-R1,HUC2-344-R2
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Phase 1 Study in Diabetes Mellitus(Fasting)
Details : HUC2-344 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Diabetes Mellitus.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 13, 2024
Details:
The agreement aims for the registration and marketing of Cyclosporine Ophthalmic Nanoemulsion, generic of Restasis, in Mexico.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Brand Name: Restasis-Generic
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: Lupin Ltd
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 22, 2024
Lead Product(s) : Cyclosporine
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Lupin Ltd
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lupin, Huons Sign Deal To Commercialize Cyclosporine in Mexico
Details : The agreement aims for the registration and marketing of Cyclosporine Ophthalmic Nanoemulsion, generic of Restasis, in Mexico.
Product Name : Restasis-Generic
Product Type : Peptide, Unconjugated
Upfront Cash : Undisclosed
July 22, 2024
Details:
HUC3-053 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dry Eye Syndromes.
Lead Product(s): HUC3-053
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 29, 2024
Lead Product(s) : HUC3-053
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
To Evaluate the Efficacy and Safety of HUC3-053 in Patients with Dry Eye Syndrome
Details : HUC3-053 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dry Eye Syndromes.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 29, 2024
Details:
NCP112 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Xerophthalmia.
Lead Product(s): NCP112
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 16, 2024
Lead Product(s) : NCP112
Therapeutic Area : Ophthalmology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Clinical Study for the Evaluation of Safety and Tolerability of NCP112 Eye Drops
Details : NCP112 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Xerophthalmia.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
February 16, 2024
Details:
HU007 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dry Eye Syndromes.
Lead Product(s): HU007
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 24, 2023
Lead Product(s) : HU007
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
HU007 in Patients with Dry Eye Syndrome
Details : HU007 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dry Eye Syndromes.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 24, 2023
Details:
HU-045 is a Protein drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Glabellar Lines.
Lead Product(s): HU-045
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Protein
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 28, 2022
Lead Product(s) : HU-045
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Phase 2 of HU-045 in Glabellar Lines
Details : HU-045 is a Protein drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Glabellar Lines.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
March 28, 2022
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
Dosage Form : INJECTABLE; SPINAL
Proprietary Name : BUPIVACAINE HYDROCHLORID...
Dosage Strength : 0.75%
Approval Date : 2019-12-30
Application Number : 212822
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : LIDOCAINE HYDROCHLORIDE
Dosage Strength : 1%
Approval Date : 2020-05-07
Application Number : 212821
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : LIDOCAINE HYDROCHLORIDE
Dosage Strength : 2%
Approval Date : 2023-06-15
Application Number : 212821
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
Inspections and registrations
GDUFA
API Manufacturer :
FDF Manufacturer :
Facility Name : Huons Co., Ltd
Business Address : 100, Bio Valley-Ro Jecheon-S...
FEI Number : 3007163376
Country : South Korea
Paid in : 2019
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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