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Anifrolumab: formulation via AI

Phase 1

Systemic Lupus Erythematosus | Small molecule | Immunology |AstraZeneca PLC|Last Updated: Jul 7, 2026

Target and mechanism

ModalitySmall molecule

Also known as Anifrolumab: SC formulation via AI

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment92

FDA Designations

No designations recorded

Clinical trial landscape

Anifrolumab: formulation via AI · 1 trial · 1 indication

Phase 1 1
NCT07688980Study to Characterise Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Anifrolumab Administered Subcutaneously (SC) or Intravenously (IV)Systemic Lupus Erythematosus
NOT YET_RECRUITING92 Analytics
PHASE1NOT YET_RECRUITING
Study to Characterise Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Anifrolumab Administered Subcutaneously (SC) or Intravenously (IV)
Systemic Lupus ErythematosusUnlock trial analytics

Study Endpoints

Primary Endpoints

Anifrolumab serum concentrations through Week 4
Up to Week 4

To characterise the PK exposure of SC or IV anifrolumab.

Secondary Endpoints

Percentage change from baseline in Type I interferon (IFN) 21-gene expression PD marker
Up to Week 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: SCEXPERIMENTALParticipants will receive SC anifrolumab administered via AI.
Part A: IVEXPERIMENTALParticipants will receive IV anifrolumab infusion.
Part BEXPERIMENTALParticipants will receive SC anifrolumab administered via aPFS.

Interventions

NameTypeDescription
Anifrolumab: SC formulation via AICOMBINATION_PRODUCTAnifrolumab will be administered subcutaneously via an AI.
Anifrolumab: IV formulationCOMBINATION_PRODUCTAnifrolumab will be administered intravenously.
Anifrolumab: SC formulation via aPFSCOMBINATION_PRODUCTAnifrolumab will be administered subcutaneously via an aPFS.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Participants who have a diagnosis of adult SLE according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 criteria for ≥ 24 weeks prior to signing the informed consent form (ICF). * "Clinical" Systemic Lupus Erythematosus Disease Acti...

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Recent Changes (Last 90 Days)

LOWJul 7, 2026NCT07688980NEW_TRIAL: changed
LOWJul 7, 2026NCT07688980NEW_TRIAL: changed

Frequently asked questions about Anifrolumab: formulation via AI

What is Anifrolumab used for in Systemic Lupus Erythematosus?

Anifrolumab is an investigational drug being studied for the treatment of Systemic Lupus Erythematosus (SLE). It is currently in Phase 1 clinical development, with a single active trial evaluating its pharmacokinetics, pharmacodynamics, and safety when administered subcutaneously or intravenously. The drug is not yet approved and remains under investigation.

Who makes Anifrolumab?

Anifrolumab is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting a Phase 1 clinical trial to evaluate the drug's pharmacokinetics, pharmacodynamics, and safety in patients with Systemic Lupus Erythematosus.

What phase is Anifrolumab in?

Anifrolumab is in Phase 1 clinical development. The ongoing trial, NCT07688980, is designed to characterize the drug's pharmacokinetics, pharmacodynamics, and safety when administered subcutaneously or intravenously. This is an early-stage study, and the drug remains investigational, not yet approved for any use.

What clinical trials is Anifrolumab in?

Anifrolumab is currently in one active clinical trial, identified as NCT07688980. This Phase 1 study is titled 'Study to Characterise Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Anifrolumab Administered Subcutaneously (SC) or Intravenously (IV)' and is enrolling 92 participants with Systemic Lupus Erythematosus. The trial is not yet recruiting.

Is Anifrolumab the same as Anifrolumab SC formulation via AI?

Yes, Anifrolumab is also known as Anifrolumab SC formulation via AI. This alternative name refers to the subcutaneous formulation of the drug, which is being evaluated in clinical trials alongside the intravenous route of administration. Both names refer to the same investigational drug developed by AstraZeneca for Systemic Lupus Erythematosus.