Amgen Inc.

Amgen Inc. works on 40 rare diseases tracked on Trial Friend, including Aplastic Anemia, Atypical Hemolytic Uremic Syndrome, Autoimmune Hepatitis and 37 more, with 16 recruiting clinical trials and 17 FDA-approved rare disease drugs.

Amgen is a multinational biopharmaceutical company with growing focus on rare diseases, strengthened by the 2023 acquisition of Horizon Therapeutics. The company develops therapies for rare inflammatory diseases, genetic disorders, and severe unmet medical conditions.

Type
Diversified Pharma
Ticker
AMGN
Headquarters
Thousand Oaks, United States
Founded
1980
Website
amgen.com
16
Active Rare Disease Trials
17
Approved Rare Disease Drugs
40
Rare Diseases in Portfolio
46
Years Active

Focus areas at Amgen Inc.

Within its broader pharmaceutical portfolio, Amgen Inc. has active clinical trial programs and drug development efforts across 40 rare diseases, including Aplastic Anemia, Atypical Hemolytic Uremic Syndrome, Autoimmune Hepatitis, Behçet Disease, C3 Glomerulopathy, and 35 additional rare conditions. These programs may span orphan drug designation, novel therapeutic mechanisms, and precision medicine approaches targeting the underlying causes of each disease.

The clinical trials section below shows all active and recruiting studies sponsored by Amgen Inc., sourced live from ClinicalTrials.gov. Each trial includes its current recruitment status, study phase (Phase 1 through Phase 4), conditions under investigation, and the number of active trial sites. The FDA-approved drugs section lists treatments that have received U.S. Food and Drug Administration approval, with brand names, generic names, approval dates, and matched rare disease indications from the openFDA database.

Amgen Inc. is headquartered in Thousand Oaks, United States, founded in 1980, publicly traded under the ticker symbol AMGN. The company maintains a dedicated rare disease division alongside its broader therapeutic portfolio, working to bring innovative treatments to patients with conditions that have historically had limited or no treatment options.

Amgen Inc. Drug Pipeline

Amgen Inc. has 16 active clinical trials across 5 development stages, with 16 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline includes all of Amgen Inc.'s active interventional trials, not only those targeting rare diseases. We show the full pipeline because a company's broader research activity, therapeutic expertise, and development infrastructure directly shape its ability to advance rare disease programs. A strong overall pipeline often signals deeper clinical operations, faster enrollment capabilities, and greater commitment to bringing new treatments to patients.

Understand Amgen Inc.'s pipeline
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2
Early Phase / Phase 12 trials
Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)
Recruiting
NF1+4 more
Recruiting
5
Phase 25 trials
Melanoma+4 more
Recruiting
Acute Myeloid Leukemia+1 more
Recruiting
7
Phase 37 trials
Neovascular Age-related Macular Degeneration+1 more
Recruiting
Non-Small Cell Lung Cancer (NSCLC)
Recruiting
1
Phase 4 / Post-Market1 trial
1
Other1 trial

Amgen Inc. Clinical Trials (16)

Active and recruiting clinical trials sponsored by Amgen Inc., sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

Ask about Amgen Inc.'s trials
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RECRUITINGPHASE3Recently updatedNCT07614776

A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration

Intervention: ABP 938 8 mg, Aflibercept (US) 8 mg

Neovascular Age-related Macular DegenerationnAMD

The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)

Ages 50 Years+69 locations
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RECRUITINGPHASE3Recently updatedNCT05920356

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)

Intervention: Sotorasib, Pembrolizumab

Non-Small Cell Lung Cancer (NSCLC)

The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

Ages 18 Years - 100 Years420 locations
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RECRUITINGPHASE1, PHASE2Recently updatedNCT06814496

Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors

Intervention: Tarlatamab, Concurrent Radiation Therapy, Sequential Radiation therapy

MelanomaMedullary Thyroid CancerSinonasal Undifferentiated CarcinomaEsthesioneuroblastomaBladder Cancer

Phase I study to examine safety of the addition of concurrent tarlatamab with standard palliative and consolidative RT regimens , with a main cohort of N=20-24 patients with extracranial anatomic radiation sites. I) After lead in of 10 patients demonstrating safety of treatment, allow for expansion to cranial sites of disease (N=6-10) with continued enrollment in main cohort II) If toxicity criteria is not met in concurrent RT tarlatamab cohort, we will continue with sequential RT, either A) delivered within 7 days prior to cycle 1 day 1, or B) delivered during cycle 1 -2 but with pre- and post-RT washout of 7 days with no drug during RT, to examine safety in a temporally spaced setting. III) If sequential tarlatamab and radiation is not deemed safe, we would allow for continued enrollment to assess efficacy of drug sans radiation treatment, enriching for tumors not of small cell lung cancer histology and allowing for patients without sites amenable to RT. A nested phase II study will attempt to assess for ORR and safety of study intervention amongst tumors not of small cell lung cancer histology.

Ages 18 Years - 99 Years3 locations
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RECRUITINGPHASE1Recently updatedNCT07403721

AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors

Intervention: AMG 436

Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)

The primary objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for AMG 436 as monotherapy and in combination with other anti-cancer therapies in participants with MSI-H/dMMR solid tumors.

Ages 18 Years - 99 Years25 locations
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RECRUITINGPHASE2Recently updatedNCT06529731

Interferon-γ (IFN-γ) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation

Intervention: Interferon gamma-1b, Donor Leukocyte Infusion (DLI)

Acute Myeloid LeukemiaMyelodysplastic Syndromes

This phase 2 study aims to confirm the efficacy observed in the prior phase 1 trial in Cohort 1 and to evaluate the safety of IFN-γ in combination with DLI in Cohort 2, the haploidentical donor alloSCT recipient cohort. The study will further contribute to this effort through the collection of leukemia cells pre- and post-in vivo IFN-γ therapy. As in the previously conducted phase 1 trial, this trial will assess whether leukemia blasts are responsive to IFN-γ in vitro and in vivo. Single-cell RNA sequencing (scRNAseq) will be performed to evaluate transcriptomic changes induced by IFN-γ in leukemia cell subsets, including those with stem cell characteristics.

Ages 18 Years+3 locations
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ACTIVE NOT RECRUITINGPHASE1, PHASE2Recently updatedNCT06401044

A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease

Intervention: AMG 732, Placebo

The primary objective of Part A of this study is to investigate the safety and tolerability of AMG 732 after single subcutaneous (SC) doses. The primary objective of Part B of this study is to investigate the efficacy of AMG 732 in participants with Thyroid Eye Disease (TED) after multiple SC doses.

Ages 18 Years - 65 Years44 locations
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ACTIVE NOT RECRUITINGPHASE3Recently updatedNCT05583227

Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

Intervention: Tezepelumab, Tezepelumab, Placebo

A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized pre-filled syringe (APFS) versus placebo in adult and adolescent patients with eosinophilic esophagitis (EoE).

Ages 12 Years - 80 Years124 locations
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Amgen Inc. FDA-Approved Drugs (17)

Medications developed or marketed by Amgen Inc. that have received U.S. Food and Drug Administration approval. Drug data is sourced from the openFDA database and includes brand names, generic names, approval dates, and matched rare disease indications. Where a drug treats a condition covered by Trial Friend, the disease name links directly to that disease page.

Drug NameBrand NameRare DiseasesApproval Date
DARBEPOETIN ALFA
Erythropoiesis-stimulating Agent [EPC]
ARANESP
intravenous, subcutaneous
Sep 17, 2001
INFLIXIMAB-AXXQ
Tumor Necrosis Factor Blocker [EPC]
AVSOLA
intravenous
Dec 6, 2019
ECULIZUMAB-AEEB
Complement Inhibitor [EPC]
BKEMV
intravenous
May 28, 2024
IVABRADINECorlanor
oral
Apr 22, 2019
EPOETIN ALFAEPOGEN
intravenous, subcutaneous
Jun 1, 1989

Amgen Inc. Trial Locations

Amgen Inc. clinical trials are running at 1,085 sites in 51 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

United States
195▼
Japan
95▼
China
83▼
Spain
58▼
Poland
54▼
France
53▼
Italy
47▼
Brazil
43▼
Argentina
32▼
Turkey (Türkiye)
31▼
Greece
25▼
Canada
24▼

Rare Disease Focus Areas (40)

Diseases targeted by Amgen Inc.'s clinical trial and drug development programs

Aplastic AnemiaBlood & Immune

Aplastic anemia is a rare bone marrow failure syndrome characterized by pancytopenia resulting from absent or severely reduced hematopoiesis. Approximately half are immune-mediated, while others resul...

Prevalence: 1-2 cases per 1 million people per year
Atypical Hemolytic Uremic SyndromeKidney & Renal

Atypical Hemolytic Uremic Syndrome (aHUS) is a rare kidney disease caused by uncontrolled activation of the complement system, a part of the immune system that normally helps fight infection. This act...

Prevalence: Approximately 1-2 cases per million people per year; rare form of HUS accounting for 5-10% of all HUS cases
Autoimmune HepatitisGastrointestinal

Autoimmune Hepatitis (AIH) is a chronic liver disease characterized by persistent inflammation and progressive fibrosis of the liver due to loss of immune tolerance to hepatocyte antigens. The immune ...

Prevalence: Approximately 0.1 to 1.9 per 100,000 people globally depending on region; accounts for 10-20% of chronic hepatitis cases
Behçet DiseaseAutoimmune & Inflammatory

Behçet Disease is a rare, chronic, recurrent vasculitis causing painful oral and genital ulcers, eye inflammation, and skin lesions. It can affect multiple organ systems including the brain, heart, an...

Prevalence: Estimated 3-300 cases per 100,000 depending on geography; highest in Turkey (370 per 100,000), common in Middle East and East Asia, rare in North America and Northern Europe
C3 GlomerulopathyKidney & Renal

C3 glomerulopathy is a group of rare kidney diseases caused by dysregulation of the alternative complement pathway, leading to uncontrolled C3 deposition in the glomeruli. The two subtypes, C3 glomeru...

Prevalence: 1 to 2 new cases per million per year; approximately 5,000 to 10,000 affected individuals in the U.S.
Chronic Graft-versus-Host DiseaseBlood & Immune

Chronic graft-versus-host disease is an immune-mediated complication after allogeneic stem cell or bone marrow transplant, in which donor immune cells attack the recipient's tissues. It can affect the...

Prevalence: Affects 30 to 70% of patients who receive allogeneic hematopoietic stem cell transplant; approximately 14,000 new cases annually in the U.S.

Patient Resources

Organizations and resources related to Amgen Inc.'s rare disease focus areas

Frequently Asked Questions About Amgen Inc.

Common questions about Amgen Inc.'s rare disease programs, clinical trials, and treatments.