ARROWHEAD PHARMACEUTICALS, INC. (ARWR)
Arrowhead Pharmaceuticals, Inc., founded in 1989 and based in Pasadena, California, is a biopharmaceutical company dedicated to discovering and advancing innovative treatments for complex and challenging-to-treat diseases within the United States. The company's extensive therapeutic pipeline primarily leverages RNA interference (RNAi) technology. Among its advanced clinical programs are: ARO-AAT, a Phase II therapeutic targeting liver diseases associated with alpha-1 antitrypsin deficiency; ARO-APOC3, which is undergoing both Phase 2b and Phase 3 clinical evaluations for hypertriglyceridemia; ARO-ANG3, currently in Phase 2b development to reduce the production of angiopoietin-like protein 3; and ARO-HIF2, a Phase 1b candidate designed to treat clear cell renal cell carcinoma. Arrowhead also has several compounds in earlier clinical development, including ARO-HSD in Phase 1/2a for other liver diseases, ARO-ENaC in Phase 1/2a, aimed at decreasing the epithelial sodium channel alpha subunit in lung airways, and ARO-C3, also in Phase 1/2a, for complement-mediated diseases. Further expanding its diverse portfolio, the company is actively developing ARO-Lung2 for chronic obstructive pulmonary disorder (COPD), ARO-DUX4 for facioscapulohumeral muscular dystrophy, ARO-XDH for uncontrolled gout, and ARO-COV for COVID-19 and other pulmonary-borne pathogens. Beyond its core internal programs, Arrowhead is involved in the progression of JNJ-3989, a subcutaneously administered RNAi therapeutic for chronic hepatitis B virus infection; Olpasiran, intended to reduce apolipoprotein A production; and ARO-AMG1, which targets genetically validated cardiovascular pathways. Strategic collaborations are integral to Arrowhead's development efforts. The company holds a licensing and research agreement with Janssen Pharmaceuticals, Inc. for the co-development of ARO-JNJ1, ARO-JNJ2, and ARO-JNJ3, all RNAi therapeutics focused on liver-expressed targets. Additionally, Arrowhead has a licensing and research partnership with Takeda Pharmaceuticals U.S.A., Inc. to develop an RNAi therapeutic candidate specifically for liver disease.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Arrowhead Pharmaceuticals, Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Completed
Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)
Plozasiran, Placebo
Familial Chylomicronemia
NCT05089084Enrollment75StartDec 2021Primary CompletionApr 2024CompletionApr 2026 - Phase 3Completed
Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia
Plozasiran Injection, Placebo
Severe Hypertriglyceridemia
NCT06347003Enrollment446StartJul 2024Primary CompletionJun 2026CompletionAug 2026 - Phase 3Completed
Study of Plozasiran in Adults With Severe Hypertriglyceridemia
Plozasiran Injection, Placebo
Severe Hypertriglyceridemia
NCT06347016Enrollment311StartJul 2024Primary CompletionJun 2026CompletionSep 2026 - Phase 3Completed
Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
Plozasiran Injection, Placebo
Hypertriglyceridemia
NCT06347133Enrollment1,456StartMay 2024Primary CompletionJun 2026CompletionSep 2026 - Phase 3Active, not recruiting
Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
Plozasiran Injection
Hypertriglyceridemia
NCT06822790Enrollment710StartApr 2025Primary CompletionJul 2028est.CompletionJul 2028est. - Phase 3Recruiting
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
Plozasiran, Placebo
Severe Hypertriglyceridemia
NCT06880770Enrollment288StartApr 2025Primary CompletionMar 2029est.CompletionJun 2029est. - Phase 3Active, not recruiting
A Phase 3 Study of Zodasiran in Adolescent and Adult Subjects With Homozygous Familial Hypercholesterolemia (YOSEMITE)
zodasiran Injection, Placebo
Homozygous Familial Hypercholesterolemia
NCT07037771Enrollment70StartJun 2025Primary CompletionAug 2027est.CompletionAug 2027est. - Phase 3Recruiting
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Zodasiran
Homozygous Familial Hypercholesterolemia
NCT07473843Enrollment10StartOct 2026est.Primary CompletionJul 2028est.CompletionAug 2028est. - Phase 2Terminated
A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
ARC-520, Placebo
Hepatitis B, Chronic
NCT02065336Enrollment58StartMar 2014Primary CompletionJan 2017CompletionJan 2017 - Phase 2Withdrawn
Study of ARC-520 in Patient With Chronic Hepatitis B Virus
ARC-520 Injection
Chronic Hepatitis B
NCT02349126Enrollment0StartFeb 2015Primary CompletionDec 2015est.CompletionMar 2016est. - Phase 2Terminated
Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus
ARC-520, Placebo
Chronic Hepatitis B
NCT02452528Enrollment4StartAug 2015Primary CompletionDec 2016CompletionDec 2016 - Phase 2Terminated
Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)
ARC-520, entecavir
Hepatitis B, Hepatitis D
NCT02577029Enrollment79StartDec 2015Primary CompletionDec 2016CompletionDec 2016 - Phase 2Terminated
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection
ARC-520 Injection, entecavir
Hepatitis B
NCT02604199Enrollment58StartSep 2015Primary CompletionJan 2017CompletionJan 2017 - Phase 2Terminated
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection
ARC-520, entecavir
Hepatitis B
NCT02604212Enrollment32StartNov 2015Primary CompletionDec 2016CompletionDec 2016 - Phase 2Terminated
Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection
ARC-520 Injection, entecavir
Hepatitis B
NCT02738008Enrollment12StartMar 2016Primary CompletionDec 2016CompletionDec 2016 - Phase 2Withdrawn
Safety, Tolerability and Effect of ARC-AAT Injection on Circulating and Intrahepatic Alpha-1 Antitrypsin Levels
ARC-AAT Injection
Alpha-1 Antitrypsin Deficiency
NCT02900183Enrollment0StartOct 2016est.Primary CompletionNov 2016CompletionNov 2016 - Phase 2Completed
Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT)
Fazisiran Injection
Alpha 1-Antitrypsin Deficiency
NCT03945292Enrollment40StartAug 2019Primary CompletionNov 2021CompletionSep 2023 - Phase 2Completed
Study of Fazirsiran (TAK-999, ARO-AAT) in Patients With Alpha-1 Antitrypsin Deficiency Associated Liver Disease (AATD)
ARO-AAT
Alpha 1-Antitrypsin Deficiency
NCT03946449Enrollment16StartOct 2019Primary CompletionApr 2022CompletionDec 2023 - Phase 2Completed
Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia
ARO-APOC3, Placebo
Severe Hypertriglyceridemia
NCT04720534Enrollment229StartMay 2021Primary CompletionMar 2023CompletionAug 2023 - Phase 2Completed
Study of ARO-ANG3 in Adults With Mixed Dyslipidemia
ARO-ANG3, Placebo
Mixed Dyslipidemia
NCT04832971Enrollment204StartJun 2021Primary CompletionAug 2022CompletionSep 2024 - Phase 2Completed
Study of Plozasiran (ARO-APOC3) in Adults With Mixed Dyslipidemia
ARO-APOC3, Placebo
Mixed Dyslipidemia
NCT04998201Enrollment353StartSep 2021Primary CompletionFeb 2023CompletionAug 2023 - Phase 2Terminated
Study of ARO-ANG3 in Participants With Homozygous Familial Hypercholesterolemia (HOFH)
ARO-ANG 3 Injection
Homozygous Familial Hypercholesterolemia
NCT05217667Enrollment18StartApr 2022Primary CompletionMay 2023CompletionNov 2025 - Phase 2Completed
Study of ARO-APOC3 in Adults With Dyslipidemia
ARO-APOC3
Dyslipidemias
NCT05413135Enrollment418StartJul 2022Primary CompletionSep 2025CompletionSep 2025 - Phase 2Recruiting
Study of Inhaled ARO-RAGE in Allergen-induced Mild Asthma
ARO-RAGE, Placebo
Asthma
NCT07241546Enrollment36StartMar 2026Primary CompletionDec 2027est.CompletionApr 2028est. - Phase 2Not yet recruiting
A Trial to Evaluate the Efficacy and Safety of ARO-INHBE in Adults With Metabolic Dysfunction-Associated Steatohepatitis
ARO-INHBE, Placebo
Metabolic Dysfunction-Associated Steatohepatitis
NCT07859813Enrollment252StartSep 2026est.Primary CompletionOct 2029est.CompletionOct 2029est.
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Completed | Plozasiran, Placebo | NCT05089084 |
| Phase 3 | Completed | Plozasiran Injection, Placebo | NCT06347003 |
| Phase 3 | Completed | Plozasiran Injection, Placebo | NCT06347016 |
| Phase 3 | Completed | Plozasiran Injection, Placebo | NCT06347133 |
| Phase 3 | Active, not recruiting | Plozasiran Injection | NCT06822790 |
| Phase 3 | Recruiting | Plozasiran, Placebo | NCT06880770 |
| Phase 3 | Active, not recruiting | zodasiran Injection, Placebo | NCT07037771 |
| Phase 3 | Recruiting | Zodasiran | NCT07473843 |
| Phase 2 | Terminated | ARC-520, Placebo | NCT02065336 |
| Phase 2 | Withdrawn | ARC-520 Injection | NCT02349126 |
| Phase 2 | Terminated | ARC-520, Placebo | NCT02452528 |
| Phase 2 | Terminated | ARC-520, entecavir | NCT02577029 |
| Phase 2 | Terminated | ARC-520 Injection, entecavir | NCT02604199 |
| Phase 2 | Terminated | ARC-520, entecavir | NCT02604212 |
| Phase 2 | Terminated | ARC-520 Injection, entecavir | NCT02738008 |
| Phase 2 | Withdrawn | ARC-AAT Injection | NCT02900183 |
| Phase 2 | Completed | Fazisiran Injection | NCT03945292 |
| Phase 2 | Completed | ARO-AAT | NCT03946449 |
| Phase 2 | Completed | ARO-APOC3, Placebo | NCT04720534 |
| Phase 2 | Completed | ARO-ANG3, Placebo | NCT04832971 |
| Phase 2 | Completed | ARO-APOC3, Placebo | NCT04998201 |
| Phase 2 | Terminated | ARO-ANG 3 Injection | NCT05217667 |
| Phase 2 | Completed | ARO-APOC3 | NCT05413135 |
| Phase 2 | Recruiting | ARO-RAGE, Placebo | NCT07241546 |
| Phase 2 | Not yet recruiting | ARO-INHBE, Placebo | NCT07859813 |
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