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AKB-9090

Phase 1

Undisclosed | Small molecule | Other |Akebia Therapeutics, Inc.|Trials Updated: Oct 6, 2026

AKB-9090 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2026

AKB-9090 target and mechanism

Molecular targetHIF-PH
Target classEnzyme
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

AKB-9090 clinical trials

AKB-9090 · 1 trial · 1 indication

Phase 1 1
NCT07429006SAD and MAD Study of AKB-9090 in Healthy Adult ParticipantsHealthy Volunteers
RECRUITING44 Analytics
PHASE1RECRUITING
SAD and MAD Study of AKB-9090 in Healthy Adult Participants
Healthy Volunteers
NCT0742900644
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Study Endpoints

Primary Endpoints

Number of participants who will report serious Treatment emergent adverse events (TEAEs) and TEAEs
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Physical Examinations
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Vital Signs
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG)
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Chemistry parameters
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Hematology Parameters
from first dose to Day 7
Number of Participants with Clinically Significant Changes in Lipid Parameters
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Coagulation Parameters
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Urinalysis Parameters
From First Dose to Day 7

Secondary Endpoints

Stage 1 SAD Cohorts: Maximum observed plasma concentration (Cmax) of AKB-9090
At Day 1
Stage 1 SAD Cohorts: Time of maximum plasma concentration (Tmax) of AKB-9090
At Day 1
Stage 1 SAD Cohorts: Area under concentration time curve (AUC) from time 0 to the last observation (AUClast) of AKB-9090
At Day 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AKB-9090EXPERIMENTALParticipants will receive a single intravenous (IV) dose of AKB-9090 at 4 escalating dose levels in the SAD stage and at 1 dose level in the MAD stage.
PlaceboPLACEBO_COMPARATORSingle IV dose of matching Placebo.

Interventions

NameTypeDescription
AKB-9090DRUGAKB-9090 will be administered intravenously
PlaceboOTHERMatching Placebo administered intravenously
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Healthy adult participants with no clinically significant findings, as judged by the investigator, based on physical examination, 12-lead ECG, alcohol breath test, and clinical laboratory tests (including serum chemistry, hematology, coagulation, urine drug screen, and uri...

Countries:New Zealand
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Recent Changes (Last 90 Days)

LOWOct 6, 2026NCT07429006lastUpdatePostDate: changed
LOWOct 6, 2026NCT07429006lastUpdatePostDate: changed
HIGHSep 9, 2026NCT07429006Enrollment: 70 → 44
HIGHSep 9, 2026NCT07429006Enrollment: 70 → 44

Frequently asked questions about AKB-9090

What is AKB-9090?

AKB-9090 is an investigational small molecule being developed by Akebia Therapeutics, Inc. It is in Phase 1 clinical development, with a single recruiting trial in healthy adult volunteers. The specific medical conditions it is intended to treat have not been disclosed.

What does AKB-9090 target?

AKB-9090 targets HIF-PH, which stands for hypoxia-inducible factor prolyl hydroxylase. HIF-PH is an enzyme, and AKB-9090 is a small molecule designed to act on it. This places AKB-9090 in the HIF-PH inhibitor class of compounds.

Who makes AKB-9090?

AKB-9090 is being developed by Akebia Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol AKBA. Akebia is the sponsor of the clinical program evaluating this investigational small molecule.

What phase is AKB-9090 in?

AKB-9090 is in Phase 1 clinical development. It is an investigational drug and is not approved for any indication. The program currently consists of one Phase 1 trial that is actively recruiting participants.

What clinical trials is AKB-9090 in?

AKB-9090 is being studied in one clinical trial, NCT07429006, titled a SAD and MAD Study of AKB-9090 in Healthy Adult Participants. The trial is a Phase 1, randomized, double-blind, placebo-controlled study with an planned enrollment of 44 healthy adult volunteers in New Zealand.

Other drugs targeting HIF-PH

FG-4592 KYNB· PHASE3

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