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FDA APPROVED COMPARATOR

Rusfertide

A specialist peptide precedent in haematology, extending the authorised comparator set beyond metabolic medicine.

Conceptual three-dimensional molecular signature for Rusfertide; not an exact chemical structure.
Hepcidin mimetic peptideConceptual molecular signature · not an exact chemical structure
Record version 1.0Last verified 10 September 2026Evidence grade AAuthorised product precedent
FDA STATUS

FDA approved as Mimrylo on 28 August 2026 for erythrocytosis in adults with polycythaemia vera

MHRA / UK LICENCE

UK status is not established in this record; no UK approval is inferred from the FDA action

NICE STATUS

No NICE recommendation identified in this record

NHS ACCESS

No NHS access is inferred from the FDA approval

PRIVATE LAWFUL USE CONTEXT

US approval does not create a UK licence or routine UK availability

EVIDENCE MATURITY

FDA authorised evidence for a defined specialist haematology indication

DEVELOPMENT PHASE

Authorised product precedent

MARKET EXPOSURE

Specialist

PROFESSIONAL RELEVANCE

Track any future UK authorisation, NICE activity and specialist pathway requirements without importing the US status into UK claims.

Product, formulation and indication

Mimrylo

US · Injection

Erythrocytosis in adults with polycythaemia vera

Status history

Mimrylo approval of 28 August 2026 added as a new FDA authorised comparator.

FDA approved specialist haematology comparator

Future material changes will be appended with their previous status and source; they will not be silently overwritten.

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Source labels identify what each link can prove. Sponsor material is used for time sensitive development claims only.