COMPANY
Celltrion
FDA-approved therapeutic company Clinical Phase 3
Timeline
- Trial start I: Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration of L03TD1 in Healthy Volunteers source ↗
- Trial start Phase 1: A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P52 in Healthy Male Subjects source ↗
- FDA FDA Original approval: AVTOZMA (tocilizumab-anoh) — BLA761498, Jan 21, 2026. Applicant at approval: CELLTRION, Inc. Biosimilar. source ↗
- FDA FDA Original approval: OSENVELT; STOBOCLO (denosumab-bmwo) — BLA761404/ORIG2, Oct 29, 2025. Applicant at approval: Celltrion, Inc. Biosimilar. source ↗
- FDA FDA Original approval: EYDENZELT (aflibercept-boav) — BLA761377, Oct 2, 2025. Applicant at approval: CELLTRION, Inc. Biosimilar. source ↗
- Trial start Phase 1: Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects source ↗
- Trial start Phase 1: A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers source ↗
- Trial start I: Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration of CT-L03 in Healthy Volunteers source ↗
- Trial start Phase 3: A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed source ↗
- Trial start Phase 3: Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin source ↗
- Trial start Phase 1: A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects source ↗
- Trial start Phase 3: A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients With Moderate to Severe Psoriasis source ↗
- FDA FDA Original approval: STEQEYMA (ustekinumab-stba) — BLA761338/ORIG2, Apr 30, 2025. Applicant at approval: CELLTRION, Inc. Biosimilar. source ↗
- Trial start Phase 1: To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab) source ↗
- FDA FDA Original approval: OMLYCLO (omalizumab-igec) — BLA761399, Mar 7, 2025. Applicant at approval: Celltrion, Inc. Biosimilar. source ↗
- FDA FDA Original approval: OSENVELT; STOBOCLO (denosumab-bmwo) — BLA761404, Feb 28, 2025. Applicant at approval: CELLTRION, Inc. Biosimilar. source ↗
- Trial start Phase 3: A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer source ↗
- FDA FDA Original approval: AVTOZMA (tocilizumab-anoh) — BLA761420, Jan 24, 2025. Applicant at approval: Celltrion, Inc. Biosimilar. source ↗
- Trial start 3: A Phase 3 Study to Evaluate Efficacy & Safety of Subcutaneous CT-P13 in Patients With Moderate to Severe Active Rheumatoid Arthritis source ↗
- FDA FDA Original approval: STEQEYMA (ustekinumab-stba) — BLA761338, Dec 17, 2024. Applicant at approval: CELLTRION, Inc. Biosimilar. source ↗
- Trial start Phase 3: Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin source ↗
- Trial start Phase 1: To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy Subjects source ↗
- Trial start Phase 3: A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis source ↗
- Trial start Phase 1: A Bioequivalence Study of L04TD3 Compared to Administration of L04RD1 in Healthy Volunteers source ↗
- Trial start Phase 3: A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid Arthritis source ↗
Upcoming milestones
- 2026-12 (ESTIMATED) · Phase 3 · Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin · NCT07093476
- 2027-02 (ESTIMATED) · Phase 3 · A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer · NCT06939595
- 2027-02 (ESTIMATED) · Phase 3 · A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis · NCT05906992
- 2027-03 (ESTIMATED) · · A Study to Evaluate the Safety of Remsima® SC in the Treatment of RA, AS, PsA and Ps · NCT05866614
- Nov 15, 2027 (ESTIMATED) · Phase 3 · A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple · NCT06952478
Clinical trials (lead sponsor) Showing 50 of 77
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07533539 | Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration of L03TD1 in Healthy Volunteers | I | Completed | May 9, 2026 | May 28, 2026 (actual) |
| NCT07367958 | A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P52 in Healthy Male Subjects | Phase 1 | Completed | Jan 26, 2026 | Jul 1, 2026 (actual) |
| NCT06939595 | A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer | Phase 3 | Active, not recruiting | Jan 30, 2025 | 2027-02 (estimated) |
| NCT06571591 | Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin | Phase 3 | Completed | Aug 27, 2024 | Apr 16, 2026 (actual) |
| NCT06738719 | A Phase 3 Study to Evaluate Efficacy & Safety of Subcutaneous CT-P13 in Patients With Moderate to Severe Active Rheumatoid Arthritis | 3 | Completed | Jan 3, 2025 | Jun 25, 2025 (actual) |
| NCT06687928 | To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab) | Phase 1 | Completed | Mar 26, 2025 | Aug 5, 2025 (actual) |
| NCT05866614 | A Study to Evaluate the Safety of Remsima® SC in the Treatment of RA, AS, PsA and Ps | Not listed | Active, not recruiting | Jan 13, 2023 | 2027-03 (estimated) |
| NCT06951828 | A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects | Phase 1 | Completed | May 30, 2025 | Nov 26, 2025 (actual) |
| NCT06630559 | A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients With Moderate to Severe Psoriasis | Phase 3 | Active, not recruiting | May 26, 2025 | Feb 18, 2026 (actual) |
| NCT07200986 | Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects | Phase 1 | Active, not recruiting | Sep 17, 2025 | Mar 31, 2026 (estimated) |
| NCT07158346 | Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration of CT-L03 in Healthy Volunteers | I | Completed | Aug 18, 2025 | Oct 3, 2025 (actual) |
| NCT07128654 | A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers | Phase 1 | Completed | Sep 17, 2025 | Oct 5, 2025 (actual) |
| NCT05385770 | Study to Evaluate and Compare the Efficacy and Safety of AZM and AML Combined and Alone in Mild-to-moderate Essential Hypertensive Subjects | Phase 3 | Completed | Jul 8, 2022 | Jul 11, 2024 (actual) |
| NCT06952478 | A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma | Phase 3 | Recruiting | Aug 12, 2025 | Nov 15, 2027 (estimated) |
| NCT07093476 | Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin | Phase 3 | Recruiting | Jul 18, 2025 | 2026-12 (estimated) |
| NCT04426890 | To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria | Phase 3 | Completed | Dec 9, 2020 | Oct 21, 2022 (actual) |
| NCT07054970 | To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy Subjects | Phase 1 | Completed | Jan 12, 2024 | Aug 29, 2024 (actual) |
| NCT03676192 | To Compare Efficacy and Safety of CT-P16 and European Union-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer | Phase 3 | Completed | Feb 1, 2019 | Apr 22, 2021 (actual) |
| NCT01084876 | Demonstrate Efficacy and Safety of Metastatic Breast Cancer | Phase 3 | Completed | 2010-06 | 2012-07 (actual) |
| NCT01084863 | Evaluate Safety, Efficacy and Pharmacokinetics | Phase 1/Phase 2 | Completed | 2010-02 | 2011-12 (actual) |
| NCT02557308 | An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis | Not listed | Terminated | May 26, 2015 | Feb 28, 2021 (actual) |
| NCT02557295 | An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With RA | Not listed | Terminated | Dec 17, 2013 | Mar 2, 2020 (actual) |
| NCT05489224 | A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis | Phase 3 | Completed | Sep 14, 2022 | Jun 29, 2023 (actual) |
| NCT05495568 | To Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis | Phase 3 | Completed | Nov 7, 2022 | Aug 14, 2023 (actual) |
| NCT04757376 | A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis | 3 | Completed | Jun 17, 2021 | May 18, 2023 (actual) |
| NCT05906992 | A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis | Phase 3 | Recruiting | Jan 11, 2024 | 2027-02 (estimated) |
| NCT04739306 | Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema | Phase 3 | Completed | Jul 22, 2021 | Oct 14, 2022 (actual) |
| NCT03945019 | CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD) | Phase 3 | Completed | Oct 28, 2019 | Aug 23, 2022 (actual) |
| NCT04205643 | CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC) | Phase 3 | Completed | Sep 1, 2020 | Jul 7, 2022 (actual) |
| NCT06037395 | Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects | I | Completed | Oct 6, 2021 | Oct 20, 2022 (actual) |
| NCT05993806 | A Bioequivalence Study of L04TD3 Compared to Administration of L04RD1 in Healthy Volunteers | Phase 1 | Completed | Jun 2, 2023 | Jun 12, 2023 (actual) |
| NCT04673786 | A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis | Phase 3 | Completed | Jan 11, 2021 | Aug 4, 2021 (actual) |
| NCT04018313 | To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects | Phase 1 | Completed | May 28, 2020 | Mar 27, 2021 (actual) |
| NCT05617183 | Compare the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects | Phase 1 | Unknown status (ClinicalTrials.gov) | Nov 15, 2022 | 2023-04 (estimated) |
| NCT04418297 | A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy | I | Terminated | Oct 23, 2020 | Nov 22, 2022 (actual) |
| NCT05725434 | A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid Arthritis | Phase 3 | Unknown status (ClinicalTrials.gov) | Feb 6, 2023 | Apr 1, 2023 (estimated) |
| NCT05364164 | A Food Effect Study of CT-L01 After Oral Administration in Healthy Volunteers | Phase 1 | Completed | Jul 9, 2022 | Jul 19, 2022 (actual) |
| NCT05568121 | A Bioequivalence Study of L04TD1 Compared to Administration of L04RD1 in Healthy Volunteers | Phase 1 | Completed | Sep 1, 2022 | Oct 9, 2022 (actual) |
| NCT05363384 | A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 25 mg and MET XR 1,000 mg) in Healthy Volunteers | Phase 1 | Completed | Jun 11, 2022 | Jun 21, 2022 (actual) |
| NCT05363592 | A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 12.5 mg and MET XR 500 mg) in Healthy Volunteers | Phase 1 | Completed | Jun 25, 2022 | Jul 5, 2022 (actual) |
| NCT05581693 | A Bioequivalence Study of L04TD2 Compared to Administration of L04RD1 in Healthy Volunteers | Phase 1 | Completed | Sep 30, 2022 | Nov 1, 2022 (actual) |
| NCT03511066 | A Study to Evaluate the Efficacy and Safety of CT-P27 in Acute Uncomplicated Influenza A Infection | Phase 2 | Terminated | Dec 9, 2016 | Mar 9, 2018 (actual) |
| NCT05017168 | To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects | Phase 1 | Completed | Oct 11, 2021 | Nov 12, 2021 (actual) |
| NCT02162667 | Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer | Phase 3 | Completed | 2014-06 | May 26, 2016 (actual) |
| NCT05224856 | To Evaluate the Safety and Efficacy of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With COVID-19 Not Requiring Supplemental Oxygen | Phase 3 | Withdrawn | 2022-04 | 2022-11 (estimated) |
| NCT04602000 | A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 Infection | 2 | Completed | Oct 5, 2020 | May 21, 2021 (actual) |
| NCT04593641 | This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19) | 1 | Completed | Sep 4, 2020 | Oct 26, 2020 (actual) |
| NCT02326155 | To Evaluate the Safety and Efficacy of Remsima™ in Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC) | Not listed | Terminated | Dec 8, 2014 | Feb 28, 2020 (actual) |
| NCT05188378 | A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects | Phase 1 | Unknown status (ClinicalTrials.gov) | Dec 22, 2021 | Oct 1, 2022 (estimated) |
| NCT05009368 | A Drug-Drug Interaction Study of CTL0901 and CTL0902 Compared to Coadministration in Healthy Adult Volunteers | Phase 1 | Completed | Jul 23, 2021 | Oct 8, 2021 (actual) |
FDA records (last 2 years)
- FDA Original approval: AVTOZMA (tocilizumab-anoh) — BLA761498, Jan 21, 2026. Applicant at approval: CELLTRION, Inc. Biosimilar. source ↗
- FDA Original approval: OSENVELT; STOBOCLO (denosumab-bmwo) — BLA761404/ORIG2, Oct 29, 2025. Applicant at approval: Celltrion, Inc. Biosimilar. source ↗
- FDA Original approval: EYDENZELT (aflibercept-boav) — BLA761377, Oct 2, 2025. Applicant at approval: CELLTRION, Inc. Biosimilar. source ↗
- FDA Original approval: STEQEYMA (ustekinumab-stba) — BLA761338/ORIG2, Apr 30, 2025. Applicant at approval: CELLTRION, Inc. Biosimilar. source ↗
- FDA Original approval: OMLYCLO (omalizumab-igec) — BLA761399, Mar 7, 2025. Applicant at approval: Celltrion, Inc. Biosimilar. source ↗
- FDA Original approval: OSENVELT; STOBOCLO (denosumab-bmwo) — BLA761404, Feb 28, 2025. Applicant at approval: CELLTRION, Inc. Biosimilar. source ↗
- FDA Original approval: AVTOZMA (tocilizumab-anoh) — BLA761420, Jan 24, 2025. Applicant at approval: Celltrion, Inc. Biosimilar. source ↗
- FDA Original approval: STEQEYMA (ustekinumab-stba) — BLA761338, Dec 17, 2024. Applicant at approval: CELLTRION, Inc. Biosimilar. source ↗
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