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Ironwood Pharmaceuticals Announces FDA Orphan Drug Designation for Olinciguat for the Treatment of Sickle Cell Disease


Ironwood Pharmaceuticals, Inc., a commercial biotech company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to olinciguat (IW-1701) for the treatment of patients with sickle cell disease. Olinciguat is an orally administered soluble guanylate cyclase (sGC) stimulator.

Ironwood is currently enrolling patients in STRONG-SCD, a multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase II trial evaluating olinciguat for the potential treatment of sickle cell disease. Ironwood expects to enroll approximately 80 patients into the Phase II trial, which is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of olinciguat in patients with sickle cell disease. Further details about the trial can be found at clinicaltrials.gov using the identifier number NCT03285178.

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