Arrowhead’s Pipeline and Timelines: A Snapshot from OnPoint
A closer look at Arrowhead’s clinical programs, shifting timelines, and what OnPoint reveals when you line the record up side by side.
Arrowhead Pharmaceuticals has spent the last decade positioning itself as one of the leaders in RNAi drug development.
Its TRiM™ platform is now powering a broad pipeline of candidates spanning cardiometabolic disease, pulmonary disorders, muscle conditions, and more. The company’s “20 in 25” ambition — to have 20 clinical or marketed drugs by 2025 — has created both momentum and scrutiny. With so many moving pieces, it can be difficult to track what’s active, what’s delayed, and where the next milestones lie.
That’s where OnPoint, an AI Institutional Memory system, comes in. Built only on primary sources — SEC filings, trial registries, press releases, and investor transcripts — OnPoint is designed to remember everything, reconcile contradictions, and keep the corporate story straight. What follows is a snapshot of Arrowhead’s pipeline and upcoming timelines as organized by OnPoint.
Arrowhead at a Glance
Arrowhead Pharmaceuticals is an RNAi therapeutics company developing medicines that silence the genes driving intractable disease. At the center of its approach is the proprietary Targeted RNAi Molecule (TRiM™) platform, designed for deep and durable gene silencing through tissue-specific targeting. Arrowhead emphasizes the structural simplicity of TRiM and its capacity for rapid innovation.
The company’s strategic ambition, expressed in its “20 in 25” initiative, is to have 20 clinical or marketed drugs by 2025. Today, Arrowhead counts 16 clinical-stage programs (8 wholly-owned, 8 partnered), and plans to add 2–3 new clinical entries each year. Its pipeline spans cardiometabolic disease, pulmonary disorders, muscle and liver conditions, and increasingly, extra-hepatic areas such as the CNS, adipose tissue, and solid tumors.
Arrowhead positions itself not only as a leader in liver-targeted RNAi, but as one of the first companies pushing the technology beyond the liver into broader therapeutic domains.
Pipeline Overview by Therapeutic Area
As of July 2025, Arrowhead’s clinical pipeline encompasses 16 programs, with equal balance between wholly-owned and partnered candidates:
Cardiometabolic Programs
Plozasiran (formerly ARO-APOC3) — Phase 3, wholly-owned
Zodasiran (formerly ARO-ANG3) — Phase 3, wholly-owned
Olpasiran — Phase 3, partnered with Amgen
ARO-PNPLA3 — Phase 1, wholly-owned
GSK-4532990 (formerly ARO-HSD) — Phase 2b, partnered with GSK
ARO-INHBE — Phase 1/2a, wholly-owned
ARO-ALK7 — Phase 1/2a, wholly-owned
Pulmonary Programs
ARO-RAGE — Phase 1/2a, wholly-owned
SRP-1002 (ARO-MMP7) — Phase 1/2a, partnered with Sarepta
Liver & Complement-Mediated Disease Programs
Fazirsiran (formerly ARO-AAT) — Phase 3, partnered with Takeda & Arrowhead
GSK5637608 (formerly JNJ-3989) — Phase 2, partnered with GSK
ARO-C3 — Phase 1/2a, wholly-owned
ARO-CFB — Phase 1/2a, wholly-owned
Neuromuscular & CNS Programs
SRP-1001 (ARO-DUX4) — Phase 1/2a, partnered with Sarepta
SRP-1003 (ARO-DM1) — Phase 1/2a, partnered with Sarepta
ARO-ATXN2 — Phase 1/2, partnered with Sarepta (CNS target)
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💡 Pipeline Count Clarification
In April 2025, Arrowhead reported 14 clinical-stage programs (10 wholly-owned, 4 partnered). By July, the figure had shifted to 16 programs (8 wholly-owned, 8 partnered).The change reflected:
• Two discontinuations — ARO-MUC5AC and ARO-SOD1.
• Four re-included partnered programs — Olpasiran (Amgen), Fazirsiran (Takeda), and two GSK programs (GSK-4532990 and GSK5637608).This illustrates the dynamic nature of Arrowhead’s disclosures: program counts shift not only because of new science, but also because of how the company chooses to frame its pipeline at a given moment.
It’s also why systems like OnPoint matter — they remember both versions, explain the reason for the shift, and prevent older guidance from being forgotten once new numbers appear.
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Timelines and Milestones Ahead
The first half of 2025 brought Arrowhead several pivotal achievements: the Sarepta collaboration closed ($825M upfront), the plozasiran NDA was accepted by FDA, $100M was earned on the DM1 milestone, and enrollment wrapped in three plozasiran Phase 3 studies. Zodasiran entered its own pivotal trial (YOSEMITE), ARO-ALK7 began clinical dosing, and ARO-C3 produced positive topline data.
Looking to the remainder of the year, milestones still ahead include:
Plozasiran: FDA decision (PDUFA November 18, 2025) and potential first commercial launch in FCS.
ARO-DM1: A second enrollment milestone could bring in $200M from Sarepta by year-end.
Zodasiran (YOSEMITE): Targeting full enrollment this summer.
Obesity programs: ARO-INHBE expected to advance; ARO-ALK7, now dosing, will expand rapidly.
Fazirsiran: Takeda guiding for full enrollment of Phase 3 REDWOOD by year-end.
ARO-RAGE: Partnership decision anticipated.
Some programs have been discontinued or deprioritized (MUC5AC, SOD1), while others have been accelerated (obesity programs) or positioned for partnership (ARO-RAGE). These moves underscore Arrowhead’s strategy of balancing internal development with selective partnerships.
All of this feeds into the company’s “20 in 25” goal: building toward 20 clinical-stage or marketed programs by year-end through a mix of growth, diversification, and collaboration.
Closing Reflection
Arrowhead’s breadth makes it both exciting and hard to follow. For investors, scientists, or analysts, the challenge isn’t just reading the disclosures — it’s remembering them, tracking the subtle changes, and keeping timelines aligned. That’s the role of OnPoint: to provide a living institutional memory that holds the record straight.
This report is part of Primary Source AI, where I’m building systems grounded solely in filings, disclosures, and trial registries. If you’d like to follow as the story unfolds — and as the tools themselves develop — you can subscribe for future updates.
Disclaimer: Primary Source AI posts are based on primary company disclosures and archival analysis. They are provided for context and education only, and should not be taken as investment advice. Always do your own due diligence.