Drug Profile
Nomlabofusp - Larimar Therapeutics
Alternative Names: CTI 1601; Tat-frataxin; TAT-FXNLatest Information Update: 14 Mar 2024
Price :
$50
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At a glance
- Originator Indiana University; Wake Forest University School of Medicine
- Developer Larimar Therapeutics
- Class Recombinant fusion proteins
- Mechanism of Action Frataxin protein replacements
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Phase II Friedreich's ataxia
Most Recent Events
- 11 Mar 2024 Larimar Therapeutics announces intention to submit BLA for accelerated approval to the US FDA for Friedreich’s Ataxia in the second half of 2025
- 11 Mar 2024 Larimar Therapeutics initiates enrolment in a phase-II open label extension trial for Friedreich's ataxia in USA (SC)
- 12 Feb 2024 Larimar Therapeutics completes a meeting with US FDA regarding the use of tissue FXN levels as a novel surrogate endpoint