Company History

Founded in 1996 in Sweden as Cortendo AB, our original focus was on regulating cortisol secretion in patients with diabetes.

In the course of reinventing, refocusing, and reinvigorating the company, Strongbridge Biopharma has reached a series of pivotal business and clinical milestones.

Strategic Acquisitions

In December 2016, Strongbridge Biopharma acquired the U.S. rights to KEVEYIS® (dichlorphenamide). This acquisition is part of our commitment to expand our portfolio and help meet the needs of patients with rare diseases that are underdiagnosed and undertreated.

Key Milestones

Recent business and clinical milestones reflect our focus on rare diseases and our organizational agility in meeting the challenges of drug development and commercialization.
Sep 2019

Announced levoketoconazole Phase 3 SONICS data published in The Lancet Diabetes & Endocrinology

Dec 2018

Announced closing of transaction with Novo Nordisk to transfer rights to Macrilen™ (macimorelin) in the United States and Canada

Aug 2018

Reported positive top-line results from the pivotal Phase 3 SONICS study of levoketoconazole for the treatment of endogenous Cushing’s syndrome

Jul 2018

Launched Macrilen (macimorelin) for Adult Growth Hormone Deficiency

Jan 2018

Acquired Macrilen (macimorelin) from Aeterna Zentaris for the diagnosis of Adult Growth Hormone Deficiency

Jul 2017

Last patient enrolled (LPI) in phase 3 SONICS trial of RECORLEV (levoketoconazole) for endogenous Cushing's syndrome

Apr 2017

Launched KEVEYIS (dichlorphenamide) for Primary Periodic Paralysis

Dec 2016

Acquired KEVEYIS (dichlorphenamide) from Taro Pharmaceutical Industries for Primary Periodic Paralysis

Jun 2015

Acquired veldoreotide, being studied for acromegaly, from Aspireo Pharmaceuticals

Aug 2014

First patient enrolled in phase 3 SONICS trial of RECORLEV (levoketoconazole) in endogenous Cushing's syndrome

Aug 2012

Levoketoconazole received EU orphan drug designation

Mar 2012

Levoketoconazole received US orphan drug designation

Feb 2012

Pivoted RECORLEV (levoketoconazole) focus from diabetes to Cushing's syndrome

Please see KEVEYIS Important Safety Information and Full Prescribing Information. Please see Macrilen Important Safety Information and Full Prescribing Information.

The safety and efficacy of RECORLEV (levoketoconazole) and veldoreotide have not been established.
Learn more about our investigational therapies

RECORLEV® (levoketoconazole) and veldoreotide

© 2020 Strongbridge Biopharma plc
STRONGBRIDGE BIOPHARMA® is a registered trademark of the Strongbridge Biopharma plc. companies, which include Strongbridge Dublin Limited and Strongbridge U.S. Inc.
KEVEYIS® is a registered trademark licensed exclusively in the U.S. to Strongbridge Biopharma plc.
MLR-0010 V18 05/2020

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