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Full Name:Regeneron Pharmaceuticals Inc. Industry:pharmaceuticals CIK:872589 Fiscal Year End:12-31 State/Country:NEW YORK

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US clinical trial status

Size of symbol reflects the phase of clinical trial. E.g. Phase 3 trial has the largest size.
Shape definition
Up-triangle: study first submitted.
Square: study completion(actual/anticipated).
Circle: result first posted.
Color definition
Green: study is ongoing.
Blue: recruitment completed.
Red: study aborted/terminated/withdrawn.
Pink: study in abnormal state.

US FDA submission

Size of symbol reflects the type of submission. E.g. Type 1 drug has the largest size.
: Approved.
: Tentative Approval.

Drug marketing & current status

Circle bubble denotes new drug marketing. Size is determined by drug type and market(i.e. population) size. E.g. Type 1 drug marketed in US has the largest size. Drug marketed in CA has the smallest size due to small population size.
Color definition
Blue circle: drug marketed (EU,CA), FDA submission approved (US).
Cyan circle: drug approved (CA), tentative approval (US), received positive opinion (EU)
Red circle: drug marketed/approved on the corresponding day but was later withdrawn, discontinued, cancelled, or received negative opinion.

Drug marketing status change

Square bubble denotes marketing status change. Size is determined by drug type and market(i.e. population) size.
Color definition
Blue square: change from other status to marketed.
Cyan square: change from other status to tentative status.
Red square: change from other status to abnormal or withdrawn status.

US Clinical Trials

Clinical Trials Summary Statistics

Year Recruiting Active, Not Recruiting Not Yet Recruiting Completed Suspended Terminated Withdrawn
ALL 10 4 3 73 7 1
2024 2
2023 1 2 1
2022 4 5
Year Recruiting Active, Not Recruiting Not Yet Recruiting Completed Suspended Terminated Withdrawn
ALL 11 2 2 2 3
2024 2
2023 2
2022
Year Recruiting Active, Not Recruiting Not Yet Recruiting Completed Suspended Terminated Withdrawn
ALL 8 6 5 39 1 10 5
2024 1 1 2
2023 1 3
2022 3 1 1
Year Recruiting Active, Not Recruiting Not Yet Recruiting Completed Suspended Terminated Withdrawn
ALL 4 4 4
2024
2023 3
2022 1
Year Recruiting Active, Not Recruiting Not Yet Recruiting Completed Suspended Terminated Withdrawn
ALL 12 4 2 39 8 1
2024 1
2023 7 1
2022 2
Year Recruiting Active, Not Recruiting Not Yet Recruiting Completed Suspended Terminated Withdrawn
ALL 1 5 1
2024
2023
2022 1
Year Recruiting Active, Not Recruiting Not Yet Recruiting Completed Suspended Terminated Withdrawn
ALL 1 1 1
2024
2023
2022 1 1
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 10 11 8 4 12 1 1
2024 1
2023 1 2 1 3 7
2022 4 3 1 2 1
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 4 2 6 4 4
2024 1
2023 2
2022 1
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 3 2 5 2
2024 2 2 2 1
2023 1 3 1
2022
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 73 2 39 4 39 5 1
2024
2023
2022 5 1 1
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 1
2024
2023
2022
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 7 3 10 8 1 1
2024
2023
2022 1
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 1 5 1
2024
2023
2022
Phase Recruiting Active, Not Recruiting Not Yet Recruiting Completed Suspended Terminated Withdrawn
Phase 1 10 4 3 73 7 1
Phase 1|Phase 2 11 2 2 2 3
Phase 2 8 6 5 39 1 10 5
Phase 2|Phase 3 4 4 4
Phase 3 12 4 2 39 8 1
Phase 4 1 5 1
Others 1 1 1
Phase Recruiting Active, Not Recruiting Not Yet Recruiting Completed Suspended Terminated Withdrawn
Phase 1 2
Phase 1|Phase 2 2
Phase 2 1 1 2
Phase 2|Phase 3
Phase 3 1
Phase 4
Others
Phase Recruiting Active, Not Recruiting Not Yet Recruiting Completed Suspended Terminated Withdrawn
Phase 1 1 2 1
Phase 1|Phase 2 2
Phase 2 1 3
Phase 2|Phase 3 3
Phase 3 7 1
Phase 4
Others
Phase Recruiting Active, Not Recruiting Not Yet Recruiting Completed Suspended Terminated Withdrawn
Phase 1 4 5
Phase 1|Phase 2
Phase 2 3 1 1
Phase 2|Phase 3 1
Phase 3 2
Phase 4 1
Others 1 1

Note: "Year" represents clinical trail start year determined by study first submit date.
Three grouping strategies present the same statistical data from different angles, choose any one you are comfortable with.
at least one study with latest update posted within 7 days.  at least one study with latest update posted within 30 days.  at least one study with latest update posted within 90 days. 

Clinical Trials Records

Sponsor Overall Status Phase Brief Title Disease Condition Intervention Name Study First Submit Date Last Update Post Date Results First Post Date Completion Date Completion Date Type Enrollment Count
Regeneron Pharmaceuticals Not yet recruiting Phase 3 A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma Melanoma fianlimab|cemiplimab|relatlimab+nivolumab 2024-01-30 2024-02-07 2033-04-14 Anticipated 560
Regeneron Pharmaceuticals Recruiting Phase 3 A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma B-Cell Non-Hodgkin Lymphoma (B-NHL) Odronextamab|Ifosfamide|Carboplatin|Etoposide|Rituximab|Dexamethasone 2023-12-29 2024-04-05 2027-07-06 Anticipated 216
Regeneron Pharmaceuticals Recruiting Phase 3 A Trial to Learn if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Participants With Follicular Lymphoma and Marginal Zone Lymphoma Relapsed/Refractory Follicular Lymphoma|Marginal Zone Lymphoma (MZL) Odronextamab|Lenalidomide|Rituximab 2023-11-20 2024-04-10 2029-10-04 Anticipated 470
Regeneron Pharmaceuticals Recruiting Phase 3 A Study to Learn How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Compared to Rituximab and Chemotherapy in Adult Participants With Previously Untreated Follicular Lymphoma Follicular Lymphoma (FL) Odronextamab|Rituximab|Cyclophosphamide|Doxorubicin|Vincristine|Prednisone/Prenisolone 2023-10-18 2024-04-17 2030-01-24 Anticipated 733
Regeneron Pharmaceuticals Recruiting Phase 3 A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Patients With Previously Untreated Diffuse Large B-cell Lymphoma Diffuse Large B-cell Lymphoma (DLBCL) Odronextamab|Rituximab|Cyclophosphamide|Doxorubicin|Vincristine|Prednisone/Prednisolone 2023-10-13 2024-04-08 2028-09-18 Anticipated 904
Regeneron Pharmaceuticals Recruiting Phase 3 A Trial to Learn if Odronextamab is Safe and Well-tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma Follicular Lymphoma (FL) Odronextamab|Rituximab|Cyclophosphamide|Doxorubicin|Vincristine|Prednisone/prednisolone 2023-10-13 2024-04-09 2029-04-03 Anticipated 478
Regeneron Pharmaceuticals Not yet recruiting Phase 3 Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS) Diabetic Macular Edema (DME)|Neovascular Age-Related Macular Degeneration (nAMD) aflibercept 8 mg PFS 2023-08-03 2024-03-08 2024-06-17 Anticipated 35
Regeneron Pharmaceuticals Recruiting Phase 2|Phase 3 A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis Eosinophilic Gastritis|Eosinophilic Duodenitis|Eosinophilic Gastrointestinal Disease Dupilumab Dose 1|Dupilumab Dose 2|Matching Placebo 2023-04-14 2024-04-12 2027-08-19 Anticipated 279
Regeneron Pharmaceuticals Recruiting Phase 2|Phase 3 A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer Non-small Cell Lung Cancer fianlimab|cemiplimab|Pemetrexed|Paclitaxel|Carboplatin|Cisplatin 2023-03-23 2024-03-20 2031-12-23 Anticipated 950
Regeneron Pharmaceuticals Recruiting Phase 2|Phase 3 A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Advanced Non-Small Cell Lung Cancer fianlimab|cemiplimab|Placebo 2023-03-14 2024-03-19 2032-02-05 Anticipated 850
Regeneron Pharmaceuticals Recruiting Phase 3 A Study to Examine the Long-term Safety, Tolerability, and Effectiveness of Pozelimab and Cemdisiran Combination Therapy in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Paroxysmal Nocturnal Hemoglobinuria Pozelimab|Cemdisiran 2023-02-06 2024-04-23 2029-05-23 Anticipated 202
Regeneron Pharmaceuticals Recruiting Phase 3 A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma Relapsed Refractory Multiple Myeloma (RRMM) Linvoseltamab|Elotuzumab|Pomalidomide|Dexamethasone 2023-02-06 2024-04-24 2032-12-26 Anticipated 380
Regeneron Pharmaceuticals Recruiting Phase 3 A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery Melanoma Fianlimab|Cemiplimab|Pembrolizumab|Placebo 2022-10-14 2024-04-22 2030-02-15 Anticipated 1530
Regeneron Pharmaceuticals Recruiting Phase 3 A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP) Fibrodysplasia Ossificans Progressiva Garetosmab|Placebo 2022-05-04 2024-04-22 2026-06-12 Anticipated 66
Regeneron Pharmaceuticals Recruiting Phase 2|Phase 3 Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma Melanoma Fianlimab|Cemiplimab|Pembrolizumab|Placebo 2022-04-06 2024-02-22 2032-08-31 Anticipated 1925

Note: Use 'Search' box on top right cornor to narrow down search results. E.g. type in "phase 3" (case insensitive, with double quote) to show Phase 3 trials.
latest update posted within 7 days.  latest update posted within 30 days.  latest update posted within 90 days. 

US FDA Submissions

US FDA Submission Summary Statistics*

Year TYPE 1 TYPE 5
ALL 7 1
2024
2023 1 1
2022

Note: "Year" determined by submission status date.
* Original submissions only. Supplementary records not counted.
at least one submission within 7 days.  at least one submission within 30 days.  at least one submission within 90 days. 

US FDA Submission Records

Sponsor Application Type Drug Name Active Ingredient Submission Code Submission Type Submission Status Status Date Application Number
Regeneron Pharmaceuticals BLA Veopoz Pozelimab Bbfg Type 1 Orig Approval 2023-08-18 761339
Regeneron Pharmaceuticals BLA Eylea Hd Aflibercept Type 5 Orig Approval 2023-08-18 761355

Note: Use 'Search' box on top right cornor to narrow down search results. E.g. type in "NDA" (case insensitive) to show records with "NDA" (New Drug Applications) tag.
submission status date within 7 days.  submission status date within 30 days.  submission status date within 90 days. 

US Drug Marketing Status
Category Sponsor Marketing Date Current Marketing Status Drug Name Active Ingredient Submission Status Date Submission Code Submission Status Marketing Status Change Date
Human Non-Bioproduct Regeneron Pharmaceuticals 2023-08-18 Prescription Eylea Hd Aflibercept 2023-08-18 Type 5 Approval 2023-11-30
Human Non-Bioproduct Regeneron Pharmaceuticals 2023-08-18 Prescription Veopoz Pozelimab Bbfg 2023-08-18 Type 1 Approval 2023-11-30

Note: This table contains human and animal drugs regulated by US FDA, and biological products regulated by CBER (Center for Biologics Evaluation and Research).
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "discontinued" (case insensitive) to show discontinued drug products.
For human non-bioproduct, marketing date was set to submission approval date.
Possible marketing statuses: Marketed, Prescription, Over-the-counter, Discontinued, None (Tentative Approval).
any of (marketing/submission/status change) within 7 days.  any of (marketing/submission/status change) within 30 days.  any of (marketing/submission/status change) within 90 days. 

EU Drug Marketing Status

No marketed drug found matching current filtering criteria

Note: This table contains human and animal drugs regulated by EMA (European Medicines Agency), and summary of opinion published by EMA based on the CHMP's or CVMP's positive or negative recommendation.
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "withdrawn" (case insensitive) to show drugs withdrawn.
Possible marketing statuses: Authorised, Refused, Withdrawn, Summary of Opinion.
Summary of Opinion: published by European Medicines Agency (EMA) based on the CHMP's or CVMP's positive or negative recommendation. Further marketing authorization is partially based on this opinion.
any of (authorization/withdrawn/opinion/status change) date within 7 days.  any of (authorization/withdrawn/opinion/status change) date within 30 days.  any of (authorization/withdrawn/opinion/status change) date within 90 days. 

CA Drug Marketing Status

No marketed drug found matching current filtering criteria

Note: This table contains human, animal drugs, radiopharmaceutical and disinfectant regulated by CFIA(Canadian Food Inspection Agency) and Health Canada.
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "marketed" (case insensitive) to show drugs marketed.
Possible marketing statuses: Marketed, Approved, Dormant, Cancelled Pre Market, Cancelled Post Market, Cancelled (Safety Issue), Cancelled (Unreturned Annual).
any of (authorization/status change) date within 7 days.  any of (authorization/status change) date within 30 days.  any of (authorization/status change) date within 90 days.