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Article ; Online: Pharmacokinetics of Voxelotor in Patients With Renal and Hepatic Impairment.

Preston, Richard A / Marbury, Thomas / Balaratnam, Ganesh / Green, Michelle / Dixon, Sandy / Lehrer-Graiwer, Josh / Washington, Carla

Journal of clinical pharmacology

2020 Volume 61, Issue 4, Page(s) 493–505

Abstract: Two open-label studies assessed the safety, tolerability, and pharmacokinetics of Oxbryta (voxelotor) in subjects with hepatic or renal impairment. Eight subjects with severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 ... ...

Abstract	Two open-label studies assessed the safety, tolerability, and pharmacokinetics of Oxbryta (voxelotor) in subjects with hepatic or renal impairment. Eight subjects with severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m
MeSH term(s)	Adult ; Aged ; Area Under Curve ; Benzaldehydes/pharmacokinetics ; Body Mass Index ; Dose-Response Relationship, Drug ; Female ; Glomerular Filtration Rate ; Half-Life ; Hematologic Agents/pharmacokinetics ; Hepatic Insufficiency/metabolism ; Humans ; Male ; Middle Aged ; Pyrazines/pharmacokinetics ; Pyrazoles/pharmacokinetics ; Renal Insufficiency/metabolism
Chemical Substances	Benzaldehydes ; Hematologic Agents ; Pyrazines ; Pyrazoles ; voxelotor (3ZO554A4Q8)
Language	English
Publishing date	2020-10-20
Publishing country	England
Document type	Clinical Trial ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	188980-1
ISSN	1552-4604 ; 0091-2700 ; 0021-9754
ISSN (online)	1552-4604
ISSN	0091-2700 ; 0021-9754
DOI	10.1002/jcph.1757
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Article: GBT440 Inhibits Sickling of Sickle Cell Trait Blood Under

Dufu, Kobina / Lehrer-Graiwer, Josh / Ramos, Eleanor / Oksenberg, Donna

Hematology reports

2016 Volume 8, Issue 3, Page(s) 6637

Abstract: In sickle cell trait (SCT), hemoglobin A (HbA) and S (HbS) are co-expressed in each red blood cell (RBC). While homozygous expression of HbS (HbSS) leads to polymerization and sickling of RBCs resulting in sickle cell disease (SCD) characterized by ... ...

Abstract	In sickle cell trait (SCT), hemoglobin A (HbA) and S (HbS) are co-expressed in each red blood cell (RBC). While homozygous expression of HbS (HbSS) leads to polymerization and sickling of RBCs resulting in sickle cell disease (SCD) characterized by hemolytic anemia, painful vaso-occlusive episodes and shortened life-span, SCT is considered a benign condition usually with minor or no complications related to sickling. However, physical activities that cause increased tissue oxygen demand, dehydration and/or metabolic acidosis leads to increased HbS polymerization and life-threatening complications including death. We report that GBT440, an agent being developed for the treatment of SCD, increases the affinity of oxygen for Hb and inhibits
Language	English
Publishing date	2016-09-28
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2586645-X
ISSN	2038-8330 ; 2038-8322
ISSN (online)	2038-8330
ISSN	2038-8322
DOI	10.4081/hr.2016.6637
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Article ; Online: Pharmacokinetics and pharmacodynamics of voxelotor (GBT440) in healthy adults and patients with sickle cell disease.

Hutchaleelaha, Athiwat / Patel, Mira / Washington, Carla / Siu, Vincent / Allen, Elizabeth / Oksenberg, Donna / Gretler, Daniel D / Mant, Timothy / Lehrer-Graiwer, Josh

British journal of clinical pharmacology

2019 Volume 85, Issue 6, Page(s) 1290–1302

Abstract: Aims: Voxelotor (previously GBT440) is a haemoglobin (Hb) modulator that increases Hb-oxygen affinity, thereby reducing Hb polymerization and sickling of red blood cells (RBCs), being developed as a once-daily oral drug to treat sickle cell disease (SCD) ...

Abstract	Aims: Voxelotor (previously GBT440) is a haemoglobin (Hb) modulator that increases Hb-oxygen affinity, thereby reducing Hb polymerization and sickling of red blood cells (RBCs), being developed as a once-daily oral drug to treat sickle cell disease (SCD). This first-in-human study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of voxelotor in healthy volunteers and SCD patients. Methods: A total of 40 healthy volunteers (100, 400, 1000, 2000 or 2800 mg) and 8 SCD patients (1000 mg) were randomly assigned to a single dose of voxelotor once daily (n = 6 per group) or placebo (n = 2 per group). Twenty-four healthy volunteers received multiple doses of voxelotor once daily for 15 days (300, 600 or 900 mg, n = 6 per group) or placebo (n = 2 per group). Results: Voxelotor was well tolerated and exhibited a linear pharmacokinetic profile and a half-life ranging from 61 ± 7 h to 85 ± 7 h. High partitioning into the RBC compartment provides evidence of highly specific binding to Hb. Voxelotor exhibited a concentration-dependent left-shift of oxygen equilibrium curves. Percent Hb modification following 900 mg voxelotor for 15 days was 38 ± 9%. Terminal half-life of voxelotor in SCD patients (50 ± 3 h) was shorter than in healthy volunteers. Evaluation of erythropoietin, exercise testing, and haematologic parameters were consistent with normal oxygen delivery during both rest and exercise. Conclusion: This first-in-human study demonstrates voxelotor was well tolerated in SCD patients and healthy volunteers and established proof of mechanism on increasing Hb-oxygen affinity.
MeSH term(s)	Adolescent ; Adult ; Anemia, Sickle Cell/blood ; Anemia, Sickle Cell/diagnosis ; Anemia, Sickle Cell/drug therapy ; Antisickling Agents/administration & dosage ; Antisickling Agents/adverse effects ; Antisickling Agents/pharmacokinetics ; Benzaldehydes/administration & dosage ; Benzaldehydes/adverse effects ; Benzaldehydes/pharmacokinetics ; Biomarkers/blood ; Double-Blind Method ; Erythrocytes/drug effects ; Erythrocytes/metabolism ; Female ; Humans ; London ; Male ; Middle Aged ; Models, Biological ; Oxyhemoglobins/metabolism ; Pyrazines/administration & dosage ; Pyrazines/adverse effects ; Pyrazines/pharmacokinetics ; Pyrazoles/administration & dosage ; Pyrazoles/adverse effects ; Pyrazoles/pharmacokinetics ; San Francisco ; Treatment Outcome ; Young Adult
Chemical Substances	Antisickling Agents ; Benzaldehydes ; Biomarkers ; Oxyhemoglobins ; Pyrazines ; Pyrazoles ; voxelotor (3ZO554A4Q8)
Language	English
Publishing date	2019-03-31
Publishing country	England
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.13896
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Article ; Online: Impact of Pharmacologically Left Shifting the Oxygen-Hemoglobin Dissociation Curve on Arterial Blood Gases and Pulmonary Gas Exchange During Maximal Exercise in Hypoxia.

Stewart, Glenn M / Cross, Troy J / Joyner, Michael J / Chase, Steven C / Curry, Timothy / Lehrer-Graiwer, Josh / Dufu, Kobina / Vlahakis, Nicholas E / Johnson, Bruce D

High altitude medicine & biology

2021 Volume 22, Issue 3, Page(s) 249–262

Abstract: Stewart, Glenn M., Troy J. Cross, Michael J. Joyner, Steven C. Chase, Timothy Curry, Josh Lehrer-Graiwer, Kobina Dufu, Nicholas E. Vlahakis, and Bruce D. Johnson. Impact of pharmacologically left shifting the oxygen-hemoglobin dissociation curve on ... ...

Abstract	Stewart, Glenn M., Troy J. Cross, Michael J. Joyner, Steven C. Chase, Timothy Curry, Josh Lehrer-Graiwer, Kobina Dufu, Nicholas E. Vlahakis, and Bruce D. Johnson. Impact of pharmacologically left shifting the oxygen-hemoglobin dissociation curve on arterial blood gases and pulmonary gas exchange during maximal exercise in hypoxia.
MeSH term(s)	Exercise Test ; Hemoglobins ; Humans ; Hypoxia ; Oxygen ; Oxygen Consumption ; Pulmonary Gas Exchange
Chemical Substances	Hemoglobins ; Oxygen (S88TT14065)
Language	English
Publishing date	2021-06-21
Publishing country	United States
Document type	Journal Article
ZDB-ID	2076262-8
ISSN	1557-8682 ; 1527-0297
ISSN (online)	1557-8682
ISSN	1527-0297
DOI	10.1089/ham.2020.0159
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Article: Impact of voxelotor (GBT440) on unconjugated bilirubin and jaundice in sickle cell disease.

Telfer, Paul / Agodoa, Irene / Fox, Kathleen M / Burke, Laurie / Mant, Timothy / Jurek, Marzena / Tonda, Margaret / Lehrer-Graiwer, Josh

Hematology reports

2018 Volume 10, Issue 2, Page(s) 7643

Abstract: For many patients with sickle cell disease (SCD), jaundice is a significant clinical disease manifestation that impacts on patient well-being. We report a case of a patient with SCD and chronic jaundice treated with voxelotor (GBT440), a novel small ... ...

Abstract	For many patients with sickle cell disease (SCD), jaundice is a significant clinical disease manifestation that impacts on patient well-being. We report a case of a patient with SCD and chronic jaundice treated with voxelotor (GBT440), a novel small molecule hemoglobin oxygen affinity modulator and potential disease-modifying therapy for SCD. The case patient is a 27-year-old Black male with a long history of SCD with clinical jaundice and scleral icterus. After starting voxelotor, the patient reported that his jaundice cleared within one week, and that he felt much better with more energy, and was relieved after his eyes cleared. Voxelotor reduced bilirubin and unconjugated bilirubin (by up to 76%), and hemoglobin improved from 9.9 g/dL at baseline to 11.1 g/dL at 90 days. Jaundice impacts many adults with SCD, significantly impacting self-image. Voxelotor treatment reduced bilirubin levels and improved jaundice, resulting in an improved sense of well-being in our case patient.
Language	English
Publishing date	2018-05-22
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2586645-X
ISSN	2038-8330 ; 2038-8322
ISSN (online)	2038-8330
ISSN	2038-8322
DOI	10.4081/hr.2018.7643
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Article ; Online: Effects of an allosteric hemoglobin affinity modulator on arterial blood gases and cardiopulmonary responses during normoxic and hypoxic low-intensity exercise.

Stewart, Glenn M / Chase, Steven / Cross, Troy J / Wheatley-Guy, Courtney M / Joyner, Michael J / Curry, Timothy / Lehrer-Graiwer, Josh / Dufu, Kobina / Vlahakis, Nicholas E / Johnson, Bruce D

Journal of applied physiology (Bethesda, Md. : 1985)

2020 Volume 128, Issue 6, Page(s) 1467–1476

Abstract: Numerous pathophysiological conditions induce hypoxemia-related cardiopulmonary perturbations, decrements in exercise capacity, and debilitating symptoms. Accordingly, this study investigated the efficacy of an allosteric hemoglobin modulator (voxelotor) ...

Abstract	Numerous pathophysiological conditions induce hypoxemia-related cardiopulmonary perturbations, decrements in exercise capacity, and debilitating symptoms. Accordingly, this study investigated the efficacy of an allosteric hemoglobin modulator (voxelotor) to enhance arterial oxygen saturation during low-intensity exercise in hypoxia. Eight normal healthy subjects (36 ± 7 yr; 73.8 ± 9.5 kg; 3 women) completed a submaximal cycling test (60 W) under normoxic ([Formula: see text]: 0.21; O
MeSH term(s)	Adult ; Exercise ; Female ; Hemoglobins ; Humans ; Hypoxia ; Male ; Oxygen ; Oxygen Consumption ; Pulmonary Gas Exchange
Chemical Substances	Hemoglobins ; Oxygen (S88TT14065)
Language	English
Publishing date	2020-04-23
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	219139-8
ISSN	1522-1601 ; 0021-8987 ; 0161-7567 ; 8750-7587
ISSN (online)	1522-1601
ISSN	0021-8987 ; 0161-7567 ; 8750-7587
DOI	10.1152/japplphysiol.00185.2019
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Article ; Online: GBT1118, a potent allosteric modifier of hemoglobin O

Dufu, Kobina / Yalcin, Ozlem / Ao-Ieong, Eilleen S Y / Hutchaleelala, Athiwat / Xu, Qing / Li, Zhe / Vlahakis, Nicholas / Oksenberg, Donna / Lehrer-Graiwer, Josh / Cabrales, Pedro

American journal of physiology. Heart and circulatory physiology

2017 Volume 313, Issue 2, Page(s) H381–H391

Abstract: Adaptation to hypoxia requires compensatory mechanisms that affect ... ...

Abstract	Adaptation to hypoxia requires compensatory mechanisms that affect O
MeSH term(s)	Adaptation, Physiological ; Administration, Oral ; Animals ; Benzaldehydes/administration & dosage ; Benzaldehydes/pharmacokinetics ; Benzaldehydes/pharmacology ; Biomarkers/blood ; Blood Flow Velocity ; Blood Pressure ; Disease Models, Animal ; Heart Rate ; Hypoxia/blood ; Hypoxia/drug therapy ; Hypoxia/physiopathology ; Male ; Mice, Inbred C57BL ; Microcirculation/drug effects ; Niacinamide/administration & dosage ; Niacinamide/analogs & derivatives ; Niacinamide/pharmacokinetics ; Niacinamide/pharmacology ; Oxygen/blood ; Oxyhemoglobins/metabolism ; Regional Blood Flow ; Severity of Illness Index ; Skin/blood supply
Chemical Substances	Benzaldehydes ; Biomarkers ; GBT1118 ; Oxyhemoglobins ; Niacinamide (25X51I8RD4) ; Oxygen (S88TT14065)
Language	English
Publishing date	2017-05-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	603838-4
ISSN	1522-1539 ; 0363-6135
ISSN (online)	1522-1539
ISSN	0363-6135
DOI	10.1152/ajpheart.00772.2016
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Article ; Online: GBT1118, a compound that increases the oxygen affinity of hemoglobin, improves survival in murine hypoxic acute lung injury.

Putz, Nathan D / Shaver, Ciara M / Dufu, Kobina / Li, Chien-Ming / Xu, Qing / Hutchaleelaha, Athiwat / Lehrer-Graiwer, Josh / Majka, Susan M / Ware, Lorraine B / Bastarache, Julie A

Journal of applied physiology (Bethesda, Md. : 1985)

2017 Volume 124, Issue 4, Page(s) 899–905

Abstract: Acute respiratory distress syndrome (ARDS) is characterized by lung inflammation and pulmonary edema, leading to arterial hypoxemia and death if the hypoxemia is severe. Strategies to correct hypoxemia have the potential to improve clinical outcomes in ... ...

Abstract	Acute respiratory distress syndrome (ARDS) is characterized by lung inflammation and pulmonary edema, leading to arterial hypoxemia and death if the hypoxemia is severe. Strategies to correct hypoxemia have the potential to improve clinical outcomes in ARDS. The goal of this study was to evaluate the potential of hemoglobin modification as a novel therapy for ARDS-induced hypoxemia. The therapeutic effect of two different doses of GBT1118, a compound that increases the oxygen affinity of hemoglobin, was evaluated in a murine model of acute lung injury induced by intratracheal LPS instillation 24 h before exposure to 5% or 10% hypoxia ( n = 8-15 per group). As expected, administration of GBT1118 to mice significantly increased the oxygen affinity of hemoglobin. Compared with mice receiving vehicle control, mice treated with GBT1118 had significantly lower mortality after LPS + 5% hypoxia (47% with vehicle vs. 22% with low-dose GBT1118, 13% with high-dose GBT1118, P = 0.032 by log rank) and had reduced severity of illness. Mice treated with GBT1118 showed a sustained significant increase in SpO
MeSH term(s)	Acute Lung Injury/drug therapy ; Acute Lung Injury/etiology ; Animals ; Benzaldehydes/pharmacology ; Benzaldehydes/therapeutic use ; Disease Models, Animal ; Drug Evaluation, Preclinical ; Hypoxia/complications ; Hypoxia/drug therapy ; Lipopolysaccharides ; Male ; Mice, Inbred C57BL ; Niacinamide/analogs & derivatives ; Niacinamide/pharmacology ; Niacinamide/therapeutic use
Chemical Substances	Benzaldehydes ; GBT1118 ; Lipopolysaccharides ; Niacinamide (25X51I8RD4)
Language	English
Publishing date	2017-12-14
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	219139-8
ISSN	1522-1601 ; 0021-8987 ; 0161-7567 ; 8750-7587
ISSN (online)	1522-1601
ISSN	0021-8987 ; 0161-7567 ; 8750-7587
DOI	10.1152/japplphysiol.00079.2017
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Article ; Online: Increased hemoglobin-oxygen affinity ameliorates bleomycin-induced hypoxemia and pulmonary fibrosis.

Geng, Xin / Dufu, Kobina / Hutchaleelaha, Athiwat / Xu, Qing / Li, Zhe / Li, Chien-Ming / Patel, Mira P / Vlahakis, Nicholas / Lehrer-Graiwer, Josh / Oksenberg, Donna

Physiological reports

2016 Volume 4, Issue 17

Abstract: Although exertional dyspnea and worsening hypoxia are hallmark clinical features of idiopathic pulmonary fibrosis (IPF), no drug currently available could treat them. GBT1118 is a novel orally bioavailable small molecule that binds to hemoglobin and ... ...

Abstract	Although exertional dyspnea and worsening hypoxia are hallmark clinical features of idiopathic pulmonary fibrosis (IPF), no drug currently available could treat them. GBT1118 is a novel orally bioavailable small molecule that binds to hemoglobin and produces a concentration-dependent left shift of the oxygen-hemoglobin dissociation curve with subsequent increase in hemoglobin-oxygen affinity and arterial oxygen loading. To assess whether pharmacological modification of hemoglobin-oxygen affinity could ameliorate hypoxemia associated with lung fibrosis, we evaluated GBT1118 in a bleomycin-induced mouse model of hypoxemia and fibrosis. After pulmonary fibrosis and hypoxemia were induced, GBT1118 was administered for eight consecutive days. Hypoxemia was determined by monitoring arterial oxygen saturation, while the severity of pulmonary fibrosis was assessed by histopathological evaluation and determination of collagen and leukocyte levels in bronchoalveolar lavage fluid. We found that hemoglobin modification by GBT1118 had strong antihypoxemic therapeutic effects with improved arterial oxygen saturation to near normal level. Moreover, GBT1118 treatment significantly attenuated bleomycin-induced lung fibrosis, collagen accumulation, body weight loss, and leukocyte infiltration. This study is the first to suggest the beneficial effects of hemoglobin modification in fibrotic lungs and offers a promising and novel therapeutic strategy for the treatment of hypoxemia associated with chronic fibrotic lung disorders in human, including IPF.
MeSH term(s)	Administration, Oral ; Animals ; Benzaldehydes/administration & dosage ; Benzaldehydes/metabolism ; Benzaldehydes/pharmacokinetics ; Benzaldehydes/pharmacology ; Bleomycin/administration & dosage ; Bleomycin/adverse effects ; Bleomycin/metabolism ; Bronchoalveolar Lavage Fluid/cytology ; Collagen/drug effects ; Collagen/metabolism ; Dyspnea/diagnosis ; Dyspnea/etiology ; Hypoxia/chemically induced ; Hypoxia/complications ; Hypoxia/drug therapy ; Idiopathic Pulmonary Fibrosis/chemically induced ; Idiopathic Pulmonary Fibrosis/drug therapy ; Idiopathic Pulmonary Fibrosis/metabolism ; Idiopathic Pulmonary Fibrosis/pathology ; Leukocytes/drug effects ; Leukocytes/metabolism ; Male ; Mice ; Mice, Inbred C57BL ; Models, Animal ; Niacinamide/administration & dosage ; Niacinamide/analogs & derivatives ; Niacinamide/metabolism ; Niacinamide/pharmacokinetics ; Niacinamide/pharmacology ; Oxygen/blood ; Oxygen/metabolism ; Oxyhemoglobins/drug effects ; Oxyhemoglobins/metabolism ; Random Allocation
Chemical Substances	Benzaldehydes ; GBT1118 ; Oxyhemoglobins ; Bleomycin (11056-06-7) ; Niacinamide (25X51I8RD4) ; Collagen (9007-34-5) ; Oxygen (S88TT14065)
Language	English
Publishing date	2016-09-13
Publishing country	United States
Document type	Journal Article
ZDB-ID	2724325-4
ISSN	2051-817X ; 2051-817X
ISSN (online)	2051-817X
ISSN	2051-817X
DOI	10.14814/phy2.12965
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