Recent Updates
Recently added Catalysts

AKB-9090

Phase 1

Healthy Volunteers | Small molecule | Other |Akebia Therapeutics, Inc.|Last Updated: Apr 13, 2026

Target and mechanism

Molecular targetHIF-PH
Target classEnzyme
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

AKB-9090 · 1 trial · 1 indication

Phase 1 1
NCT07429006SAD and MAD Study of AKB-9090 in Healthy Adult ParticipantsHealthy Volunteers
RECRUITING70 Analytics
PHASE1RECRUITING
SAD and MAD Study of AKB-9090 in Healthy Adult Participants
Healthy Volunteers
NCT0742900670
Unlock trial analytics

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AKB-9090EXPERIMENTALParticipants will receive a single intravenous (IV) dose of AKB-9090 at 5 escalating dose levels in the SAD stage and at 3 dose levels in the MAD stage.
PlaceboPLACEBO_COMPARATORSingle IV dose of matching Placebo.

Interventions

NameTypeDescription
AKB-9090DRUGAKB-9090 will be administered intravenously
PlaceboOTHERMatching Placebo administered intravenously
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about AKB-9090

What is AKB-9090 used for?

AKB-9090 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a first-in-human trial evaluating single ascending doses and multiple ascending doses. The drug is being developed by Akebia Therapeutics, Inc. (NASDAQ: AKBA).

What does AKB-9090 target?

AKB-9090 targets HIF-PH, which is an enzyme. HIF-PH, or hypoxia-inducible factor prolyl hydroxylase, plays a role in the body's response to low oxygen levels. By targeting this enzyme, AKB-9090 may influence pathways related to oxygen sensing, though its full mechanism is still under investigation.

Who makes AKB-9090?

AKB-9090 is being developed by Akebia Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker AKBA. The company is conducting clinical trials for this investigational drug in healthy volunteers.

What phase is AKB-9090 in?

AKB-9090 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to evaluate the safety, tolerability, and pharmacokinetics of the drug.

What clinical trials is AKB-9090 in?

AKB-9090 is being studied in a Phase 1 clinical trial with the identifier NCT07429006. The trial is titled 'SAD and MAD Study of AKB-9090 in Healthy Adult Participants' and is recruiting in New Zealand. It is a randomized, double-blind, placebo-controlled study with an enrollment target of 70 participants.

Is AKB-9090 the same as any other drug?

AKB-9090 is the primary name for this investigational drug. No alternative names have been disclosed in the clinical trial information. It is being studied under this name in the ongoing Phase 1 trial.