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Celltrion Inc

Celltrion Inc logo
🇰🇷South Korea
Ownership
-
Established
1999-01-01
Employees
-
Market Cap
$31.9B
Website
http://www.celltrion.com/

Clinical Trials

164

Active:73
Completed:63

Trial Phases

4 Phases

Phase 1:80
Phase 2:3
Phase 3:47
+1 more phases

Drug Approvals

48

CANADA:20
SFDA:8

Drug Approvals

OMLYCLO

Approval Date
Mar 4, 2025
CANADA

OMLYCLO

Approval Date
Mar 4, 2025
CANADA

STEQEYMA

Approval Date
Aug 29, 2024
CANADA

STEQEYMA

Approval Date
Aug 29, 2024
CANADA

STEQEYMA IV

Approval Date
Aug 29, 2024
CANADA

YUFLYMA

Approval Date
Aug 14, 2023
CANADA

YUFLYMA

Approval Date
Aug 14, 2023
CANADA

VEGZELMA

Approval Date
Aug 14, 2023
CANADA

VEGZELMA

Approval Date
May 1, 2023
CANADA

YUFLYMA

Approval Date
Mar 6, 2023
CANADA
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Clinical Trials

Distribution across different clinical trial phases (144 trials with phase data)• Click on a phase to view related trials

Phase 1
80 (55.6%)
Phase 3
47 (32.6%)
Not Applicable
14 (9.7%)
Phase 2
3 (2.1%)

Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects

Not Applicable
Recruiting
Conditions
Healthy Participants
Interventions
First Posted Date
2025-10-01
Last Posted Date
2025-10-01
Lead Sponsor
Celltrion
Target Recruit Count
218
Registration Number
NCT07200986
Locations
🇰🇷

Inje University Busan Paik Hospital, Busan, Busanjin-gu, South Korea

🇰🇷

CHA Bundang Medical Center, Seongnam-si, Gyeonggi-do, South Korea

🇰🇷

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

and more 2 locations

Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration of CT-L03 in Healthy Volunteers

Not Applicable
Recruiting
Conditions
Type 2 Diabetes Mellitus (T2DM)
Interventions
Drug: L03RD1
Drug: L03RD2
Drug: CT-L03
First Posted Date
2025-09-05
Last Posted Date
2025-09-05
Lead Sponsor
Celltrion
Target Recruit Count
48
Registration Number
NCT07158346
Locations
🇰🇷

H plus Yangji Hostpital, Seoul, South Korea

A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers

Not Applicable
Recruiting
Conditions
Healthy
Interventions
Drug: CTL02
Drug: CTL0201
Drug: CTL0202
First Posted Date
2025-08-19
Last Posted Date
2025-08-19
Lead Sponsor
Celltrion
Target Recruit Count
40
Registration Number
NCT07128654
Locations
🇰🇷

H+ Yangji Hospital, Seoul, Korea, Republic of

Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin

Not Applicable
Recruiting
Conditions
T2DM
Diabete Type 2
DM
Interventions
First Posted Date
2025-07-30
Last Posted Date
2025-08-11
Lead Sponsor
Celltrion
Target Recruit Count
171
Registration Number
NCT07093476
Locations
🇰🇷

Celltrion, Seoul, Korea, Republic of

To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy Subjects

Not Applicable
Completed
Conditions
Healthy Male Subjects
Interventions
First Posted Date
2025-07-08
Last Posted Date
2025-07-08
Lead Sponsor
Celltrion
Target Recruit Count
172
Registration Number
NCT07054970
Locations
🇯🇵

Yokohama Minoru Clinic, Yokohama-shi, Kanagawa, Japan

🇯🇵

SOUSEIKAI Nishikumamoto Hospital, Kumamoto-shi, Kumamoto, Japan

🇯🇵

Medical Corporation Heishinkai OPHAC Hospital, Osaka-shi, Osaka, Japan

and more 1 locations
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News

Hikma and Celltrion Expand Biosimilar Access Across MENA Through Exclusive Partnership

Hikma Pharmaceuticals and Celltrion Inc. have signed exclusive licensing agreements to bring six biosimilar treatments to the Middle East and North Africa region.

Celltrion Launches First Omalizumab Biosimilar Omlyclo in Europe, Starting with Norway

Celltrion has become the first pharmaceutical company to launch Omlyclo, an omalizumab biosimilar referencing Xolair, in the European market starting with Norway.

Celltrion Receives FDA Approval for EYDENZELT, First Aflibercept Biosimilar for Retinal Diseases

Celltrion's EYDENZELT (aflibercept-boav) becomes the first FDA-approved biosimilar to EYLEA for treating multiple retinal diseases including wet AMD, diabetic macular edema, and diabetic retinopathy.

Celltrion Expands Biosimilar Portfolio in Vietnam's $7.3 Billion Biopharmaceutical Market

Celltrion launched two biosimilars in Vietnam in 2024, including Remsima for autoimmune diseases and Herzuma for breast and stomach cancer.

FDA Approves Tocilizumab-anoh Biosimilar for Cytokine Release Syndrome Treatment

The FDA approved tocilizumab-anoh (Avtozma) IV formulation on August 6, 2025, for treating cytokine release syndrome in patients aged 2 years and older.

Amgen Settles Denosumab Biosimilar Patent Dispute with Accord BioPharma

Amgen and Accord BioPharma reached a settlement agreement on July 16, 2025, resolving patent litigation over Accord's denosumab biosimilar INTP23, with Accord agreeing to delay U.S. market entry until October 1, 2025.

Celltrion Secures Preferred Bidder Status for US Manufacturing Facility to Navigate Tariff Challenges

Celltrion has been named the preferred bidder for a large-scale biologics manufacturing facility in the US, with a final agreement expected in early October.

Onconic Therapeutics Advances Nesuparib to Phase 2 Trials for Pancreatic Cancer Treatment

Onconic Therapeutics has initiated Phase 2 clinical trials for Nesuparib, a dual-target anticancer drug that simultaneously inhibits Tankyrase and PARP for advanced and metastatic pancreatic cancer treatment.

McMaster Study Identifies Most Effective Treatments for Chronic Hives Through Comprehensive Meta-Analysis

A McMaster University-led international study analyzed 93 randomized controlled trials involving over 11,000 participants to identify the most effective treatments for chronic hives.

FDA Approves First Xolair Biosimilar Omlyclo for Allergic Diseases, Marking Milestone in Allergy Treatment Access

The FDA has approved Omlyclo (omalizumab-igec) as the first biosimilar interchangeable with Xolair for treating allergic asthma, chronic rhinosinusitis with nasal polyps, chronic urticaria, and food allergies.

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