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Full Name:Amgen Inc. Industry:biological products (diagnostic and non diagnostic) CIK:318154 Fiscal Year End:12-31 State/Country:CALIFORNIA

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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Red: study aborted/terminated/withdrawn.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Red circle: drug marketed/approved on the corresponding day but was later withdrawn, discontinued, cancelled, or received negative opinion.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Red square: change from other status to abnormal or withdrawn status.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Year Recruiting Active, Not Recruiting Not Yet Recruiting Completed Unknown Status Suspended Terminated Withdrawn
ALL 1 1
2024
2023 1
2022
Year Recruiting Active, Not Recruiting Not Yet Recruiting Completed Unknown Status Suspended Terminated Withdrawn
ALL 10 9 1 155 1 30 6
2024 3 1 1 1
2023 2 12 1
2022 3 2 14
Year Recruiting Active, Not Recruiting Not Yet Recruiting Completed Unknown Status Suspended Terminated Withdrawn
ALL 5 1 25 7 1
2024
2023 1
2022 1
Year Recruiting Active, Not Recruiting Not Yet Recruiting Completed Unknown Status Suspended Terminated Withdrawn
ALL 2 5 2 167 4 22 4
2024 1
2023 1 1
2022 1 1 2 1
Year Recruiting Active, Not Recruiting Not Yet Recruiting Completed Unknown Status Suspended Terminated Withdrawn
ALL 5
2024
2023
2022
Year Recruiting Active, Not Recruiting Not Yet Recruiting Completed Unknown Status Suspended Terminated Withdrawn
ALL 25 12 4 190 22 3
2024 1 4
2023 11 2 1
2022 3 3
Year Recruiting Active, Not Recruiting Not Yet Recruiting Completed Unknown Status Suspended Terminated Withdrawn
ALL 5 2 1 56 5 1
2024 1
2023 2
2022 1
Year Recruiting Active, Not Recruiting Not Yet Recruiting Completed Unknown Status Suspended Terminated Withdrawn
ALL 6 1
2024
2023
2022 1
Year Early Phase 1 Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 1 10 5 2 25 5
2024 3 1
2023 1 2 1 1 11 2
2022 3 1 3 1
Year Early Phase 1 Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 9 1 5 12 2
2024 1
2023 2
2022 2 1 3
Year Early Phase 1 Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 1 2 4 1
2024 1 1 4 1
2023 1
2022
Year Early Phase 1 Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 155 25 167 5 190 56 6
2024 1
2023 12 1
2022 14 1 1
Year Early Phase 1 Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 4
2024
2023
2022
Year Early Phase 1 Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 1
2024
2023
2022
Year Early Phase 1 Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 1 30 7 22 22 5 1
2024
2023
2022 2
Year Early Phase 1 Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 6 1 4 3 1
2024
2023 1
2022 1
Phase Recruiting Active, Not Recruiting Not Yet Recruiting Completed Unknown Status Suspended Terminated Withdrawn
Early Phase 1 1 1
Phase 1 10 9 1 155 1 30 6
Phase 1|Phase 2 5 1 25 7 1
Phase 2 2 5 2 167 4 22 4
Phase 2|Phase 3 5
Phase 3 25 12 4 190 22 3
Phase 4 5 2 1 56 5 1
Others 6 1
Phase Recruiting Active, Not Recruiting Not Yet Recruiting Completed Unknown Status Suspended Terminated Withdrawn
Early Phase 1
Phase 1 3 1 1 1
Phase 1|Phase 2
Phase 2 1
Phase 2|Phase 3
Phase 3 1 4
Phase 4 1
Others
Phase Recruiting Active, Not Recruiting Not Yet Recruiting Completed Unknown Status Suspended Terminated Withdrawn
Early Phase 1 1
Phase 1 2 12 1
Phase 1|Phase 2 1
Phase 2 1 1
Phase 2|Phase 3
Phase 3 11 2 1
Phase 4 2
Others
Phase Recruiting Active, Not Recruiting Not Yet Recruiting Completed Unknown Status Suspended Terminated Withdrawn
Early Phase 1
Phase 1 3 2 14
Phase 1|Phase 2 1
Phase 2 1 1 2 1
Phase 2|Phase 3
Phase 3 3 3
Phase 4 1
Others 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
Amgen Not yet recruiting Phase 3 Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV Vasculitis Avacopan 2024-03-14 2024-03-20 2030-04-28 Anticipated 20
Amgen Not yet recruiting Phase 3 A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer ABP 234|Pembrolizumab (US)|Pembrolizumab (EU) 2024-03-08 2024-04-02 2027-10-22 Anticipated 927
Amgen Recruiting Phase 3 A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe AD Atopic Dermatitis Rocatinlimab Prefilled Syringe 2024-01-17 2024-04-19 2026-04-22 Anticipated 100
Amgen Not yet recruiting Phase 3 Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation Metastatic Colorectal Cancer FOLFIRI Regimen|Sotorasib|Panitumumab|Bevacizumab-awwb 2024-01-15 2024-02-12 2030-11-27 Anticipated 450
Amgen Not yet recruiting Phase 3 Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab Extensive-Stage Small-Cell Lung Cancer|Small-Cell Lung Cancer Tarlatamab|Durvalumab 2024-01-08 2024-01-18 2028-09-25 Anticipated 550
Amgen Recruiting Phase 3 A Study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Participants With Moderate to Severe Plaque-type Psoriasis (PsO) Plaque Psoriasis apremilast|Placebo 2023-11-03 2024-03-28 2025-12-24 Anticipated 200
Amgen Recruiting Phase 3 Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Limited Stage Small Cell Lung Cancer|Small Cell Lung Cancer Tarlatamab|Placebo 2023-10-31 2024-04-25 2029-10-31 Anticipated 400
Amgen Recruiting Phase 3 A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis Plaque Psoriasis Apremilast 2023-10-12 2024-04-25 2026-12-17 Anticipated 50
Amgen Recruiting Phase 3 A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma Melanoma ABP 206|Nivolumab 2023-09-20 2024-04-25 2027-01-25 Anticipated 620
Amgen Recruiting Phase 3 Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta Osteogenesis Imperfecta Romosozumab|Bisphosphonate 2023-07-24 2024-04-23 2027-09-10 Anticipated 106
Amgen Recruiting Phase 3 A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma Melanoma ABP 206|FDA-licensed Nivolumab|EU-authorized Nivolumab 2023-06-08 2024-04-25 2025-07-30 Anticipated 249
Amgen Active, not recruiting Phase 3 A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER) Atopic Dermatitis|Moderate-to-severe Atopic Dermatitis Rocatinlimab|Placebo 2023-06-02 2024-03-07 2024-11-06 Anticipated 221
Amgen Recruiting Phase 3 A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202) Non-Small Cell Lung Cancer (NSCLC) Sotorasib|Pembrolizumab 2023-05-23 2024-03-22 2031-03-01 Anticipated 750
Amgen Recruiting Phase 3 A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) Atopic Dermatitis Rocatinlimab|Placebo 2023-05-22 2024-03-28 2027-06-04 Anticipated 2200
Amgen Recruiting Phase 3 A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis Behçet's Disease|Juvenile Psoriatic Arthritis Apremilast 2023-03-08 2024-02-15 2032-12-29 Anticipated 48
Amgen Recruiting Phase 3 Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer Small Cell Lung Cancer (SCLC) Tarlatamab|Lurbinectedin|Topotecan|Amrubicin 2023-02-07 2024-04-25 2027-08-01 Anticipated 490
Amgen Active, not recruiting Phase 3 A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD) Atopic Dermatitis Rocatinlimab|Placebo 2023-02-02 2024-04-24 2025-01-06 Anticipated 746
Amgen Recruiting Phase 3 A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Atopic Dermatitis Rocatinlimab|Placebo 2023-01-20 2024-04-25 2025-12-18 Anticipated 500
Amgen Completed Phase 3 A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD) Chorioretinal Vascular Disease ABP 938|Aflibercept 2023-01-20 2023-11-18 2023-03-24 Actual 49
Amgen Active, not recruiting Phase 3 A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon) Atopic Dermatitis Rocatinlimab|Placebo 2022-12-07 2024-01-08 2024-09-26 Anticipated 726
Amgen Recruiting Phase 3 A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) Atopic Dermatitis Rocatinlimab 2022-11-22 2024-04-25 2025-07-21 Anticipated 170
Amgen Active, not recruiting Phase 3 Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial Atherosclerotic Cardiovascular Disease Placebo|Olpasiran 2022-10-12 2024-04-04 2026-12-29 Anticipated 7297
Amgen Recruiting Phase 3 A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis Plaque Psoriasis Apremilast 2022-09-20 2023-10-06 2026-09-06 Anticipated 33
Amgen Recruiting Phase 3 A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE) Atopic Dermatitis Rocatinlimab|Placebo 2022-05-24 2024-04-19 2025-03-30 Anticipated 700
Amgen Active, not recruiting Phase 3 Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation Colorectal Cancer (CRC) Sotorasib|Panitumumab|Trifluridine and Tipiracil|Regorafenib 2022-01-06 2024-03-04 2025-03-12 Anticipated 160

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 2/4 TYPE 3 TYPE 5 EFFICACY UNKNOWN
ALL 15 1 1 1 1 4
2024
2023 2
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
Amgen Inc BLA Wezlana Ustekinumab Auub Unknown Orig Approval 2023-10-31 761285
Amgen Inc BLA Wezlana Ustekinumab Auub Unknown Orig Approval 2023-10-31 761331

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 Amgen Inc 2023-10-31 Prescription Wezlana Ustekinumab Auub 2023-10-31 Unknown Approval 2023-11-30
Human Non-Bioproduct Amgen Inc 2023-10-31 Prescription Wezlana Ustekinumab Auub 2023-10-31 Unknown Approval 2023-11-30
Human Non-Bioproduct Amgen Inc 2023-10-31 Prescription Wezlana Ustekinumab Auub 2023-10-31 Unknown Approval 2023-11-30
Human Non-Bioproduct Amgen Inc 2023-10-31 Prescription Wezlana Ustekinumab Auub 2023-10-31 Unknown Approval 2023-11-30
Human Non-Bioproduct Amgen Inc 2023-10-31 Prescription Wezlana Ustekinumab Auub 2023-10-31 Unknown Approval 2023-11-30
Human Non-Bioproduct Amgen Inc 2023-10-31 Prescription Wezlana Ustekinumab Auub 2023-10-31 Unknown Approval 2023-11-30
Human Non-Bioproduct Amgen Inc 2021-05-28 Prescription Lumakras Sotorasib 2021-05-28 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
Category Sponsor Authorization Date Current Marketing Status Latest Status Update Drug Name Active Ingredient Withdraw Date Opinion Date Summary of Opinion
Human Amgen Technology (Ireland) Uc 2023-04-19 Authorised 2023-05-15 Bekemv Eculizumab
Human Amgen Europe Bv 2022-01-06 Authorised 2022-03-31 Lumykras Sotorasib

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
Category Sponsor Authorization Date Current Marketing Status Status Date Drug Name Active Ingredient
Human Amgen Canada Inc 2023-12-27 Marketed 2024-03-01 Wezlana Ustekinumab (45 Mg)
Human Amgen Canada Inc 2023-12-27 Marketed 2024-03-01 Wezlana Ustekinumab (90 Mg)
Human Amgen Canada Inc 2023-12-27 Marketed 2024-03-01 Wezlana Ustekinumab (45 Mg)
Human Amgen Canada Inc 2023-12-27 Marketed 2024-03-01 Wezlana I.V. Ustekinumab (5 Mg)
Human Amgen Canada Inc 2021-03-11 Dormant 2023-12-03 Riabni Rituximab (10 Mg)
Human Amgen Canada Inc 2014-11-12 Marketed 2022-01-10 Otezla Apremilast (10 Mg)|Apremilast (20 Mg)|Apremilast (30 Mg)

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.