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Akebia Therapeutics Inc (AKBA)

(85% Positive) Akebia Therapeutics Inc (AKBA) Announces Enrollment Update for expected Due to Geopolitical Situation, Patient Enrollment Issues, Regulatory Process, Manufacturing Considerations, Safety Review, Efficacy Assessment

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  • News bot Jan. 29, 2026, 8:40 p.m.

    📋 Akebia Therapeutics Inc (AKBA) - Clinical Trial Update

    Filing Date: 2026-01-12

    Accepted: 2026-01-12 08:04:20

    Event Type: Clinical Trial Update

    Event Details:

    Akebia Therapeutics Inc (AKBA) Announces Clinical Trial Update Akebia Therapeutics Inc (AKBA) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: expected, including
    • Diseases/Conditions: its next anticipated growth driver
    • Clinical Stage: Phase 2, clinical trial
    • Collaboration: Akebia Therapeutics, Inc.
      • Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels.No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks.Use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions.CONTRAINDICATIONS•Known hypersensitivity to VAFSEO or any of its components•Uncontrolled hypertensionWARNINGS AND PRECAUTIONS•Increased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular AccessA rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis.•HepatotoxicityHepatocellular injury attributed to VAFSEO was reported in less than 1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease.•HypertensionWorsening of hypertension was reported in 14% of VAFSEO and 17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in 2.7% of VAFSEO and 3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed.•SeizuresSeizures occurred in 1.6% of VAFSEO and 1.6% of darbepoetin alfa patients. Monitor for new-onset seizures, premonitory symptoms, or change in seizure frequency.•Gastrointestinal (GI) ErosionGastric or esophageal erosions occurred in 6.4% of VAFSEO and 5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in 3.4% of VAFSEO and 3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present.•Serious Adverse Reactions in Patients with Anemia Due to CKD and Not on DialysisThe safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa.•MalignancyVAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in 2.2% of VAFSEO and 3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies.ADVERSE REACTIONS•The most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea.DRUG INTERACTIONS•Iron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron.•Non-iron-containing phosphate binders: Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders.•BCRP substrates: Monitor for signs of substrate adverse reactions and consider dose reduction.•Statins: Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg.USE IN SPECIFIC POPULATIONS•Pregnancy: May cause fetal harm.•Lactation: Breastfeeding not recommended until two days after the final dose.•Hepatic Impairment: Not recommended in patients with cirrhosis or active, acute liver disease.Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide.Forward-Looking StatementsStatements in this press release 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
      • expected in 2027
      • expected in early 2027

    🔬 Clinical Development Pipeline (Akebia Therapeutics Inc):

    Product Type Development Stage Therapeutic Area Source
    Praliciguat DRUG Phase PHASE2 Focal Segmental Glomerulosclerosis ClinicalTrials.gov
    Simvastatin DRUG Phase PHASE1 Drug Interaction Potentiation ClinicalTrials.gov
    Rosuvastatin DRUG Phase PHASE1 Drug Interaction Potentiation ClinicalTrials.gov
    Darbepoetin alfa DRUG Phase PHASE3 Anemia ClinicalTrials.gov
    Placebo OTHER Phase PHASE2 Focal Segmental Glomerulosclerosis ClinicalTrials.gov
    Vadadustat 1200mg DRUG Phase PHASE2 Nonintubated Acute Respiratory Distress Syndrome (ARDS) ClinicalTrials.gov
    Vadadustat 900mg DRUG Phase PHASE2 Nonintubated Acute Respiratory Distress Syndrome (ARDS) ClinicalTrials.gov
    IkT-148009 (risvodetinib) DRUG Phase PHASE2 Parkinson Disease ClinicalTrials.gov
    Vadadustat DRUG Phase PHASE3 Anemia of Chronic Kidney Disease ClinicalTrials.gov
    Erythropoiesis-Stimulating Agent (ESA) DRUG Phase PHASE3 Anemia of Chronic Kidney Disease ClinicalTrials.gov
    Ferrous Sulfate DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    AKB-6548 DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    Celecoxib DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    Rabeprazole DRUG Phase PHASE1 Drug Interaction Potentiation ClinicalTrials.gov
    Cyclosporins DRUG Phase PHASE1 Drug Interaction Potentiation ClinicalTrials.gov
    Probenecid DRUG Phase PHASE1 Drug Interaction Potentiation ClinicalTrials.gov
    Rifampin DRUG Phase PHASE1 Drug Interaction Potentiation ClinicalTrials.gov
    Digoxin DRUG Phase PHASE1 Drug Interaction Potentiation ClinicalTrials.gov
    Adefovir DRUG Phase PHASE1 Drug Interaction Potentiation ClinicalTrials.gov
    Furosemide DRUG Phase PHASE1 Drug Interaction Potentiation ClinicalTrials.gov
    Moxifloxacin DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    AKB-6548 (supratherapeutic dose) DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    AKB-6548 (therapeutic dose) DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    vadadustat test tablets DRUG Phase PHASE1 Healthy ClinicalTrials.gov
    vadadustat reference tablets DRUG Phase PHASE1 Healthy ClinicalTrials.gov
    AKB-6548 tablet, test formulation given in the fed state DRUG Phase PHASE1 Healthy ClinicalTrials.gov
    AKB-6548 tablet, test formulation given in the fasted state. DRUG Phase PHASE1 Healthy ClinicalTrials.gov
    AKB-6548 tablet, reference formulation given in the fasted state DRUG Phase PHASE1 Healthy ClinicalTrials.gov
    Epoetin alfa DRUG Phase PHASE1 Anemia Associated With Chronic Kidney Disease ClinicalTrials.gov
    Sulfasalazine DRUG Phase PHASE1 Drug Interaction Potentiation ClinicalTrials.gov
    Pravastatin DRUG Phase PHASE1 Drug Interaction Potentiation ClinicalTrials.gov
    Atorvastatin DRUG Phase PHASE1 Drug Interaction Potentiation ClinicalTrials.gov
    Auryxia® DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    Calcium acetate DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    Sevelamer carbonate DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    Placebo Oral Tablet DRUG Phase PHASE2 Heart Failure With Preserved Ejection Fraction ClinicalTrials.gov
    IW-1973 DRUG Phase PHASE2 Heart Failure With Preserved Ejection Fraction ClinicalTrials.gov
    Vadadustat TIW DRUG Phase PHASE2 Anemia ClinicalTrials.gov
    Standard of care phosphate-lowering therapy DRUG Phase PHASE4 Hyperphosphatemia ClinicalTrials.gov
    Ferric Citrate 1 gram Oral Tablet DRUG Phase PHASE4 Hyperphosphatemia ClinicalTrials.gov
    Mircera® DRUG Phase PHASE3 Anemia Associated With Chronic Kidney Disease (CKD) ClinicalTrials.gov
    Erythropoiesis Stimulating Agent DRUG Phase PHASE3 Anemia of Chronic Kidney Disease ClinicalTrials.gov
    Ferric Citrate 1 GM Oral Tablet [AURYXIA] DRUG Phase PHASE3 Anemia, Iron Deficiency ClinicalTrials.gov

    💼 Business Developments:

    • Partnership
    • Acquisition: Not available
    • Licensing: Not available
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: Akebia Therapeutics Inc
    • Ticker Symbol: AKBA

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