Last reviewed 2026-05-13 · How we verify

PF-06954522 IR (Formulation 1) (pf-06954522-ir-formulation-1)

PF-06954522 IR (Formulation 1) is a marketed drug by Pfizer Inc. for the treatment of Spinal Muscular Atrophy (SMA) type 1 in infants 1 month of age or older, positioning it in a niche but critical segment of the pediatric market. The drug's key strength lies in its specific indication for SMA type 1, a condition with limited therapeutic options, providing a competitive edge over broader spectrum treatments like Dabrafenib, Trametinib, and Selumetinib. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics and biosimilars.

At a glance

Approved indications

• Spinal Muscular Atrophy (SMA) with a genetically confirmed diagnosis of SMA type 1 in infants 1 month of age or older
• Spinal Muscular Atrophy (SMA) with a genetically confirmed diagnosis of SMA type 2 in children 2 months of age or older
• Spinal Muscular Atrophy (SMA) with a genetically confirmed diagnosis of SMA type 3 in children 2 months of age or older

Common side effects

No common side effects on file.

Drug interactions

• Warfarin
• P-glycoprotein inhibitors
• P-glycoprotein inducers
• CYP3A4 inhibitors
• CYP3A4 inducers

Key clinical trials

• A Study to Learn How Different Forms of the Study Medicine Called PF-06954522 Are Taken up Into the Blood in Healthy Adults (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• PF-06954522 IR (Formulation 1) CI brief — competitive landscape report
• PF-06954522 IR (Formulation 1) updates RSS · CI watch RSS
• Pfizer Inc. portfolio CI