This section highlights FDA-related milestones and regulatory updates for drugs developed by Akebia Therapeutics (AKBA).
Over the past two years, Akebia Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AKB-9090, Vadadustat, praliciguat, and XOANACYL. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
AKB-9090 FDA Regulatory Events
AKB-9090 is a drug developed by Akebia Therapeutics for the following indication: treatment of cardiac surgery-associated acute kidney injury (AKI).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AKB-9090
- Announced Date:
- April 13, 2026
- Indication:
- treatment of cardiac surgery-associated acute kidney injury (AKI).
Announcement
Akebia Therapeutics®, 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).
AI Summary
Akebia Therapeutics announced that 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. The study is testing AKB-9090 as a potential treatment for acute kidney injury (AKI) that can occur after cardiac surgery. Dosing the first participants marks the start of human testing for this candidate.
HIF-PH inhibitors work by stabilizing hypoxia-inducible factors, proteins that help cells respond to low oxygen and may protect kidney tissue after injury. As a Phase 1 trial, the study will primarily assess safety, tolerability, and appropriate dosing while also gathering early data on biological effects related to kidney protection. Positive results could support further testing in larger studies focused specifically on preventing or treating cardiac surgery–associated AKI.Read Announcement
Vadadustat FDA Regulatory Timeline and Events
Vadadustat is a drug developed by Akebia Therapeutics for the following indication: Anemia due to chronic kidney disease (CKD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Vadadustat
- Announced Date:
- January 12, 2026
- Indication:
- Anemia due to chronic kidney disease (CKD)
Announcement
Akebia Therapeutics®, today announced key corporate updates associated with its Vafseo® (vadadustat) commercial business and provided an outlook on upcoming milestones, including for its next anticipated growth driver, Akebia's mid-stage rare kidney disease pipeline.
AI Summary
Akebia said its Vafseo commercial business enters 2026 positioned to deepen prescribing, with access to about 275,000 dialysis patients and expectations that existing and new dialysis organizations will accelerate adoption. In Q4 2025 the company reported roughly 785 prescribers (an 8% increase), a rise in new patients from non‑USRC dialysis groups to at least 25%, and estimated underlying patient dosing demand of about $10.5–$11.5 million. A shift to an observed in‑center dosing protocol at some centers raised first‑refill adherence from 75% to 91% but also led to a channel inventory adjustment; Akebia expects Q4 Vafseo net product revenue of $5–$6 million and forecasts revenue growth to resume in Q1 2026.
Akebia is advancing a mid‑stage rare kidney disease pipeline as its next growth driver. The company dosed the first patient in a Phase 2 praliciguat trial for FSGS in December 2025, plans to start an open‑label Phase 2 AKB‑097 basket study in 2H 2026 (initial data expected in 2027) targeting IgA nephropathy, lupus nephritis and C3 glomerulopathy, and expects AKB‑9090 to enter Phase 1 in H1 2026.
Read Announcement- Drug:
- Vadadustat
- Announced Date:
- November 6, 2025
- Indication:
- Anemia due to chronic kidney disease (CKD)
Announcement
Akebia Therapeutics®, Inc. announced the presentation of a post-hoc win odds analysis of all-cause mortality and hospitalization from the Phase 3 INNO2VATE trials of vadadustat at the American Society of Nephrology Kidney Week 2025 (ASN Kidney Week).
AI Summary
At ASN Kidney Week 2025, Akebia Therapeutics presented a post-hoc win-odds analysis of all-cause mortality and hospitalization from its Phase 3 INNO2VATE trials comparing Vafseo (vadadustat) with the ESA darbepoetin alfa in dialysis patients. The analysis showed a statistically significant advantage for Vafseo on the combined endpoint of death or hospital stay, with an inverted win-odds ratio of 0.93 (95% CI, 0.87–0.99; P=0.03) overall and 0.86 (95% CI, 0.81–0.95; P<0.0001) on treatment plus 28 days post-dose.
Dr. Glenn Chertow of Stanford noted that the win-odds method helps prioritize important outcomes and showed Vafseo reduced the risk of death or hospitalization versus darbepoetin alfa. Vafseo, approved in the U.S. since January 2025 for dialysis patients with CKD-related anemia, can help doctors choose treatments. Steven Burke, Akebia’s Chief R&D Officer, said these results support therapy decisions in maintenance dialysis patients.
Read Announcement- Drug:
- Vadadustat
- Announced Date:
- October 28, 2025
- Indication:
- Anemia due to chronic kidney disease (CKD)
Announcement
Akebia Therapeutics® announced that after meeting with the U.S. Food and Drug Administration (FDA) it has not come to alignment on a path forward for the design of the VALOR clinical trial for the use of vadadustat to treat anemia in patients with late-stage chronic kidney disease (CKD) not on dialysis.
AI Summary
Akebia Therapeutics announced that, after a face-to-face Type C meeting with the U.S. Food and Drug Administration, they did not reach agreement on how to design the VALOR clinical trial of vadadustat for treating anemia in late-stage chronic kidney disease patients not on dialysis.
As a result, Akebia will not initiate the VALOR trial and does not plan to seek a broad label for Vafseo in non-dialysis-dependent CKD patients.
Based on the FDA’s feedback, the company believes a proper trial would require a substantially larger patient population than originally proposed. This would add significant time and cost to bring the study to completion.
Although disappointed, Akebia remains committed to finding an oral anemia treatment for non-dialysis CKD patients. They are encouraged by discussions about smaller patient subgroups and will continue working to establish Vafseo as a standard care option for dialysis patients.
Read Announcement- Drug:
- Vadadustat
- Announced Date:
- June 4, 2025
- Indication:
- Anemia due to chronic kidney disease (CKD)
Announcement
- Akebia Therapeutics®, announced that the Journal of the American Society of Nephrology (JASN) has published pre-specified analyses for the U.S. and non-U.S. patient subgroups from the vadadustat global phase 3 clinical program, which included two trials in patients with dialysis-dependent chronic kidney disease (DD-CKD; INNO2VATE) and two trials in patients with non–dialysis-dependent CKD (NDD-CKD; PRO2TECT).
AI Summary
Akebia Therapeutics® announced that the Journal of the American Society of Nephrology has published pre-specified analyses from its vadadustat global phase 3 clinical program. The program included two trials for dialysis-dependent chronic kidney disease (DD-CKD; INNO2VATE) and two trials for non–dialysis-dependent CKD (NDD-CKD; PRO2TECT). The analyses looked at both U.S. and non-U.S. patient subgroups, comparing the safety and efficacy of vadadustat with darbepoetin alfa. For U.S. patients with DD-CKD, the results showed similar safety and efficacy outcomes for both treatments. In patients with NDD-CKD, while safety and efficacy were also comparable, there was a higher risk for major adverse cardiovascular events with vadadustat outside the United States. These findings highlight how regional differences may influence trial outcomes, providing key insights for physicians treating CKD-related anemia.
Read Announcement- Drug:
- Vadadustat
- Announced Date:
- March 13, 2025
- Indication:
- Anemia due to chronic kidney disease (CKD)
Announcement
Akebia Therapeutics® recent business highlights.
AI Summary
Akebia Therapeutics recently announced strong early results for its U.S. launch of Vafseo (vadadustat) for treating anemia in chronic kidney disease patients on dialysis. The company expects net product revenues of approximately $10-$11 million in the first quarter of 2025. Vafseo began shipping on January 9, 2025, and has already received orders from three of the top four U.S. dialysis organizations. Over 500 prescribers have issued prescriptions, with the average prescriber writing about eight prescriptions.
CEO John P. Butler expressed confidence in Vafseo becoming the new standard of care for dialysis patients. Akebia is also planning to expand Vafseo’s use to non-dialysis CKD patients by meeting with the FDA to discuss the Phase 3 VALOR study protocol, aiming to initiate the trial later this year. The company’s current cash resources and cash from operations are expected to support its operating plan for at least two years.
Read Announcement- Drug:
- Vadadustat
- Announced Date:
- December 3, 2024
- Indication:
- Anemia due to chronic kidney disease (CKD)
Announcement
Akebia Therapeutics®, Inc. announced that in late November U.S. Renal Care (USRC) enrolled the first patient in its Vafseo® (vadadustat) Outcomes In-Center Experience (VOICE) collaborative trial.
AI Summary
Akebia Therapeutics® recently announced that in late November, U.S. Renal Care (USRC) enrolled the first patient in the Vafseo® (vadadustat) Outcomes In-Center Experience (VOICE) collaborative trial. This study is designed to evaluate the safety and effectiveness of Vafseo when it is administered three times a week, aligning with patients’ existing dialysis schedules. The trial aims to compare Vafseo treatment with current standard-of-care erythropoiesis-stimulating agents by assessing outcomes such as all-cause mortality and hospitalization rates. Approximately 2,200 patients are expected to be enrolled, with the study concluding about 18 months after the last patient is randomized. The trial is a key step in exploring additional benefits for chronic kidney disease patients with anemia and is part of plans leading up to the anticipated U.S. market launch of Vafseo in January 2025.
Read Announcement- Drug:
- Vadadustat
- Announced Date:
- October 10, 2024
- Indication:
- Anemia due to chronic kidney disease (CKD)
Announcement
Akebia Therapeutics®, Inc announced that the Center for Medicare & Medicaid Services (CMS) has determined that Vafseo® (vadadustat) meets the criteria for the Transitional Drug Add-On Payment Adjustment (TDAPA) in the anemia management end-stage renal disease (ESRD) prospective payment system functional category, beginning on January 1, 2025.
AI Summary
Akebia Therapeutics® announced that the Center for Medicare & Medicaid Services (CMS) has approved its drug Vafseo® (vadadustat) for the Transitional Drug Add-On Payment Adjustment (TDAPA). This means that starting January 1, 2025, Vafseo will be eligible for an extra two years of reimbursement beyond the standard ESRD bundled rate. This additional payment is designed to help dialysis organizations incorporate Vafseo into their treatment options for anemia management in patients with end-stage renal disease.
A HCPCS code has also been assigned to Vafseo to simplify the billing process for dialysis centers serving Medicare enrollees. This milestone is a key part of Akebia's strategy to bring innovative treatments to market and supports efforts to help dialysis providers offer improved care to patients with kidney disease.
Read Announcement- Drug:
- Vadadustat
- Announced Date:
- September 5, 2024
- Indication:
- Anemia due to chronic kidney disease (CKD)
Announcement
Akebia Therapeutics®, Inc. announced plans to begin a collaborative clinical trial of recently approved Vafseo. The first patient in this trial is expected to be enrolled this year.
AI Summary
Akebia Therapeutics, Inc. has announced plans to launch a collaborative clinical trial for Vafseo, a newly approved treatment for anemia in chronic kidney disease patients undergoing dialysis. The study, conducted in partnership with U.S. Renal Care, will enroll about 2,200 patients who will be randomly assigned to receive either Vafseo tablets or the standard erythropoiesis-stimulating agents. The trial is designed to investigate key outcomes, including overall mortality and hospitalization rates, while also building a robust body of real-world evidence regarding the treatment’s benefits. Notably, the first patient is expected to be enrolled later this year. This initiative aims to further explore Vafseo’s safety and its potential to become an important, orally administered option for managing anemia in dialysis patients.
Read Announcement- Drug:
- Vadadustat
- Announced Date:
- July 11, 2024
- Indication:
- Anemia due to chronic kidney disease (CKD)
Announcement
Akebia Therapeutics®, announced key updates pertaining to the commercial launch of Vafseo® (vadadustat) Tablets. Akebia will host an investor conference call at 8:00 a.m. ET on Thursday, July 11, 2024.
AI Summary
Akebia Therapeutics® provided key updates on the commercial launch of Vafseo® (vadadustat) Tablets. The company announced that it has regained full rights to market Vafseo in the U.S. after finalizing a royalty-based termination agreement with CSL Vifor. This move is designed to streamline operations, enhance economic performance, and accelerate contracting discussions with dialysis organizations, including Fresenius Kidney Care and select third-party providers.
In addition, Akebia revealed that it has set the wholesale acquisition cost (WAC) for Vafseo at $1,278 for a 30-day supply and submitted its TDAPA application in June 2024. The approval process is expected to progress with designation scheduled for January 1, 2025. The company also announced an investor conference call to discuss these commercial launch updates on Thursday, July 11, 2024, at 8:00 a.m. ET.
Read Announcement
Praliciguat FDA Regulatory Events
Praliciguat is a drug developed by Akebia Therapeutics for the following indication: Treatment of Focal Segmental Glomerulosclerosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- praliciguat
- Announced Date:
- January 6, 2026
- Indication:
- Treatment of Focal Segmental Glomerulosclerosis
Announcement
Akebia Therapeutics®, announced that the first patient has been dosed in a Phase 2 clinical trial of praliciguat, an oral, once-daily soluble guanylate cyclase (sGC) stimulator being evaluated for the treatment of biopsy-confirmed FSGS, a rare kidney disease, with plans to assess its use in other rare podocytopathies in the future.
AI Summary
Akebia Therapeutics announced the first patient has been dosed in a Phase 2 trial of praliciguat, an oral once-daily soluble guanylate cyclase (sGC) stimulator. The study will evaluate praliciguat for biopsy-confirmed focal segmental glomerulosclerosis (FSGS), and the company plans to assess the drug in other rare podocytopathies in the future.
The randomized, double-blind, placebo-controlled, multicenter trial will enroll about 60 adults who are already on maximally tolerated ACE inhibitor or angiotensin receptor blocker therapy. Participants will be randomized 1:1 to receive praliciguat or placebo for an initial 24-week period, after which all may receive open-label praliciguat for an additional 24 weeks. The primary endpoint is change from baseline in urine protein-to-creatinine ratio (UPCR) at Week 24.
The secondary endpoint is the percentage of patients with partial remission at Week 24 (defined as a 40% UPCR reduction and UPCR <1.5 g/g). Akebia says praliciguat has shown a tolerable safety profile in earlier studies and is key to its rare kidney disease program.
Read Announcement
XOANACYL FDA Regulatory Events
XOANACYL is a drug developed by Akebia Therapeutics for the following indication: Oral Therapy for Chronic Kidney Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XOANACYL
- Announced Date:
- April 3, 2025
- Indication:
- Oral Therapy for Chronic Kidney Disease
Announcement
Akebia Therapeutics®, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the European Commission (EC) to approve XOANACYL® (Ferric Citrate as Coordination Complex) for the treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD).
AI Summary
Akebia Therapeutics® announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided a positive opinion recommending that the European Commission (EC) approve XOANACYL® (Ferric Citrate as Coordination Complex). This treatment is aimed at adult patients with chronic kidney disease (CKD) who suffer from both elevated serum phosphorous and iron deficiency. The positive CHMP recommendation represents an important step forward in making a new option available to address these dual complications in CKD patients. Averoa, which holds the rights to develop and market the treatment in the European Economic Area and select countries in Europe and the Middle East, will now work toward obtaining final approval from the EC. A final decision from the EC is expected in about two months.
Read Announcement
