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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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Instructions
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▶ Red: study aborted/terminated/withdrawn.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⬤ Red circle: drug marketed/approved on the corresponding day but was later withdrawn, discontinued, cancelled, or received negative opinion.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◼ Red square: change from other status to abnormal or withdrawn status.
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Year | Recruiting | Active, Not Recruiting | Not Yet Recruiting | Completed | Suspended | Terminated | Withdrawn |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Year | Recruiting | Active, Not Recruiting | Not Yet Recruiting | Completed | Suspended | Terminated | Withdrawn |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Year | Recruiting | Active, Not Recruiting | Not Yet Recruiting | Completed | Suspended | Terminated | Withdrawn |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 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.
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.
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.
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.