PharmaRadar360

PharmaRadar360

ImmunologyDrug intelligence

Cosentyx

Secukinumab

IL-17A inhibitor. Developed by Novartis. Clinical, regulatory, and source evidence are connected below.

Company
Novartis
Target / MOA
IL-17A 路 IL17A
Aliases
Cosentyx 路 AIN457
Signals
24
Clinical trials
17
Approvals
2
Evidence sources
24

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

A Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD

N/A 路 RECRUITING 路 Novartis Pharmaceuticals

clinical trialClinicalTrials.gov

Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)

Phase 3 路 ACTIVE_NOT_RECRUITING 路 Novartis Pharmaceuticals

clinical trialClinicalTrials.gov

A Pragmatic Trial of Interleukin-17 Inhibition Versus Janus Kinase Inhibition After Tumor Necrosis Factor-alpha Inhibitor Failure in Axial Spondyloarthritis

Phase 4 路 NOT_YET_RECRUITING 路 The University of Texas Health Science Center, Houston

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 18, 2026.

United States (FDA label)

Cosentyx 路 BLA125504, BLA761349 路 label version 30, effective Aug 25, 2026 路 DailyMed

Label section 1

1 INDICATIONS AND USAGE 1.1 Plaque Psoriasis COSENTYX 庐 is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. 1.3 Ankylosing Spondylitis COSENTYX is indicated for the treatment of active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. 1.4 Non-Radiographic Axial Spondyloarthritis COSENTYX is indicated for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammation. 1.5 Enthesitis-Related Arthritis COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. 1.6 Hidradenitis Suppurativa COSENTYX is indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older.

European Union (EMA)

Cosentyx 路 EMEA/H/C/003729 路 Authorised, authorised Jan 15, 2015 (Commission decision C(2015) 203) 路 EPAR

Plaque psoriasis Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. Hidradenitis suppurativa (HS) Cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy. Psoriatic arthritis Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (DMARD) therapy has been inadequate. Axial spondyloarthritis (axSpA) Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis (nr-axSpA) Cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (NSAIDs). Juvenile idiopathic arthritis (JIA) Enthesitis-related arthritis (ERA) Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. Juvenile psoriatic arthritis (JPsA) Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 18, 2026.

United States

BLA125504 路 NOVARTIS PHARMS CORP 路 first approved Jan 21, 2015

14 efficacy supplements approved

BLA761349 路 NOVARTIS PHARMS CORP 路 first approved Oct 6, 2023

European Union

  • Cosentyx: Authorised since Jan 15, 2015

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 18, 2026.

BLA125504 (Purple Book)

No exclusivity date listed.

BLA761349 (Purple Book)

No exclusivity date listed.

Generics and biosimilars

The Purple Book lists no licensed biosimilar.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 18, 2026.

Boxed warning

The current US label has no boxed warning.

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies 路 17 linked records.

N/ARECRUITINGNCT07683065

A Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD

Novartis Pharmaceuticals 路 Updated Oct 16, 2026

Phase 3ACTIVE NOT RECRUITINGNCT06331312

Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)

Novartis Pharmaceuticals 路 Updated Oct 14, 2026

Phase 4NOT YET RECRUITINGNCT07770646

A Pragmatic Trial of Interleukin-17 Inhibition Versus Janus Kinase Inhibition After Tumor Necrosis Factor-alpha Inhibitor Failure in Axial Spondyloarthritis

The University of Texas Health Science Center, Houston 路 Updated Oct 14, 2026

Phase 4ACTIVE NOT RECRUITINGNCT05622708

A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

Novartis Pharmaceuticals 路 Updated Oct 14, 2026

Phase 1RECRUITINGNCT06751238

Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability up to 6 Years of Intravenous (i.v.) Secukinumab in Pediatric Participants With Juvenile Psoriatic Arthritis (JPsA).

Novartis Pharmaceuticals 路 Updated Oct 13, 2026

Phase 4RECRUITINGNCT04638647

Secukinumab Open Label Roll-over Extension Protocol

Novartis Pharmaceuticals 路 Updated Oct 13, 2026

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial 路 Latest Oct 16, 202620FDAofficial 路 Latest Apr 17, 20262EMA Newsofficial 路 Latest Sep 18, 20261
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.