Akebia Therapeutics Announces First Participants Dosed in Phase 1 Clinical Trial of AKB-9090
Rhea-AI Summary
Akebia Therapeutics (Nasdaq: AKBA) announced dosing of the first participants in a Phase 1 randomized, double-blind, placebo-controlled SAD/MAD trial of AKB-9090, an IV HIF-PH inhibitor for cardiac surgery-associated acute kidney injury (AKI).
The study will enroll up to 70 participants, assess safety, tolerability, pharmacokinetics and pharmacodynamics, and Akebia plans to report topline data in early 2027. Akebia also noted other kidney programs: praliciguat (Phase 2) and AKB-097 (Phase 2 planned H2 2026).
Positive
- First-in-human dosing initiated for AKB-9090
- Study sized for up to 70 participants
- Topline data expected early 2027
- IV HIF-PH mechanism targets acute care AKI
Negative
- Phase 1 trial is early-stage with no efficacy data yet
- Topline results not expected until early 2027, delaying readout
News Market Reaction – AKBA
In the Apr 13 session, AKBA gained 5.00%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jan 06 | Phase 2 FSGS start | Positive | -2.6% | First patient dosed in Phase 2 praliciguat trial for FSGS. |
| Jun 04 | Phase 3 data publish | Positive | +6.4% | Vadadustat Phase 3 CKD anemia analyses published in nephrology journal. |
| Dec 03 | Vafseo VOICE enrollment | Positive | -4.2% | First patients enrolled in large VOICE trial of Vafseo in dialysis. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial announcements have produced mixed reactions, with two negative and one positive move, and an average move of -0.15% around prior trial updates.
Recent clinical news for Akebia shows steady advancement of its kidney-focused pipeline. On Jan 6, 2026, first dosing in a Phase 2 FSGS praliciguat trial saw a -2.65% move. Publications and new enrollment for Vafseo/vadadustat trials on Jun 4, 2025 and Dec 3, 2024 drove moves of 6.43% and -4.23%, respectively. Today’s AKB-9090 Phase 1 dosing fits this pattern of incremental clinical execution in kidney and dialysis-related indications.
Key Terms
hypoxia-inducible factor-prolyl hydroxylase (hif-ph) inhibitor medical
acute kidney injury medical
randomized medical
double-blind medical
placebo-controlled medical
single and multiple ascending dose medical
pharmacokinetics medical
pharmacodynamics medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
AKB-9090 is being evaluated as a potential treatment for cardiac surgery-associated acute kidney injury
CAMBRIDGE, Mass., April 13, 2026 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the first participants have been dosed in a Phase 1 clinical trial of AKB-9090, an internally developed hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor being evaluated for the treatment of cardiac surgery-associated acute kidney injury (AKI). The Phase 1 randomized, double-blind, placebo-controlled, single and multiple ascending dose (SAD/MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AKB-9090 administered intravenously in healthy adult participants.
“AKB-9090 has been internally developed leveraging our team’s extensive expertise in HIF-PH biology, and we believe is a promising product candidate with the potential to treat acute care conditions with significant unmet need such as AKI,” said John P. Butler, Chief Executive Officer of Akebia. “We are pleased to have dosed our first study participants in the Phase 1 clinical trial and plan to report top line data in early 2027.”
The trial will enroll up to 70 participants randomized to receive either AKB-9090 or placebo across sequential single and multiple dose-escalation cohorts. The primary endpoints include the incidence of treatment-emergent adverse events and changes in clinical laboratory parameters, vital signs, and electrocardiograms. More information about this study can be found here.
In late 2025, Akebia introduced its pipeline of clinical stage kidney disease programs. In addition to AKB-9090, Akebia is evaluating praliciguat, a soluble guanylate cyclase stimulator, currently in a Phase 2 clinical trial targeting focal segmental glomerulosclerosis; and AKB-097, a next-generation tissue-targeted complement inhibitor planned to enter a Phase 2 basket trial in rare kidney diseases, including IgA nephropathy, lupus nephritis and C3 glomerulopathy, in the second half of 2026.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.
Forward-Looking Statements
Statements in this presentation regarding Akebia Therapeutics, Inc.’s (“Akebia’s”) strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding: Akebia's plans, strategies and prospects for its business; Akebia’s beliefs and expectations regarding the mechanism of action of its technologies’ and ability to address the biological need of certain diseases; Akebia’s plans and expectations with respect to AKB-9090, including the timing of the completion of the current Phase 1 trial, the number of patients to be enrolled in the trial, the timing of reporting top line data from the trial, and the indication to be evaluated, and AKB-9090’s potential for successful development and regulatory path to treat acute care conditions with significant unmet need, including AKI; Akebia’s plans and expectations with respect to praliciguat and the Phase 2 trial; and Akebia’s plans and expectations with respect to AKB-097, including the timing of initiation of an open label Phase 2 basket study and the indications to be evaluated. The terms "intend," "believe," "plan," "goal," "potential," "anticipate,” "estimate," "expect," "future," "will," "continue," “could,” derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: the potential therapeutic benefits, safety profile, and effectiveness of Vafseo and Akebia’s development candidates; the results of preclinical and clinical research; Akebia’s ability to initiate and enroll patients in its clinical trials; decisions made by health authorities, such as the FDA, with respect to regulatory filings and other interactions; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to Auryxia® and Vafseo®, including estimates regarding the potential market opportunity; the competitive landscape for Auryxia and Vafseo, including generic entrants and the timing thereof; the ability of Akebia to attract and retain qualified personnel; Akebia's ability to achieve and maintain profitability and to maintain operating expenses consistent with its operating plan; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; early termination of any of Akebia's collaborations; and changes in the geopolitical environment and uncertainty surrounding U.S. trade policy on tariffs. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Annual Report on Form 10-K for the year ended December 31, 2025, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this presentation, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this presentation.
Akebia Therapeutics®, Auryxia® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
