{"id":16,"date":"2023-07-18T19:05:44","date_gmt":"2023-07-18T19:05:44","guid":{"rendered":"https:\/\/pharmacosmosmedical.com\/staging\/1978\/?page_id=16"},"modified":"2026-04-02T11:21:07","modified_gmt":"2026-04-02T11:21:07","slug":"ferwon-clinical-trials","status":"publish","type":"page","link":"https:\/\/pharmacosmosmedical.com\/staging\/1978\/ferwon-clinical-trials\/","title":{"rendered":"FERWON Clinical Trials"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;Course Hero&#8221; _builder_version=&#8221;4.23.3&#8243; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_stops=&#8221;#131b68 0%|#9271f6 100%&#8221; background_color_gradient_start=&#8221;#474ab6&#8243; background_color_gradient_end=&#8221;#9271f6&#8243; background_image=&#8221;https:\/\/pharmacosmosmedical.com\/staging\/1978\/wp-content\/uploads\/2023\/07\/coding-background-texture.jpg&#8221; background_blend=&#8221;overlay&#8221; custom_padding=&#8221;35px|0px|0px|0px|false|false&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;top&#8221; animation_intensity_slide=&#8221;2%&#8221; da_disable_devices=&#8221;off|off|off&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; da_is_popup=&#8221;off&#8221; da_exit_intent=&#8221;off&#8221; da_has_close=&#8221;on&#8221; da_alt_close=&#8221;off&#8221; da_dark_close=&#8221;off&#8221; da_not_modal=&#8221;on&#8221; da_is_singular=&#8221;off&#8221; da_with_loader=&#8221;off&#8221; da_has_shadow=&#8221;on&#8221;][et_pb_row _builder_version=&#8221;4.27.4&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; min_height=&#8221;208.5px&#8221; custom_padding=&#8221;27px|0px|24px|0px&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.23&#8243; header_font=&#8221;|on|||&#8221; header_text_align=&#8221;center&#8221; header_font_size=&#8221;42px&#8221; header_line_height=&#8221;1.3em&#8221; background_layout=&#8221;dark&#8221; custom_padding=&#8221;|||&#8221; header_font_size_tablet=&#8221;&#8221; header_font_size_phone=&#8221;&#8221; header_font_size_last_edited=&#8221;on|desktop&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h1>FERWON Phase 3 Clinical Trials<span style=\"font-size: large; color: rgba(255, 255, 255, 0.47);\"> <\/span><\/h1>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.27.4&#8243; text_text_color=&#8221;#d4ccff&#8221; text_font_size=&#8221;16px&#8221; text_orientation=&#8221;center&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>The safety and efficacy of two different intravenous irons for treatment of iron deficiency anemia (IDA) were evaluated in two randomized, open-label, actively-controlled Phase 3 clinical trials performed in a total of 3050 patients with IDA of different etiology. Additional analyses were performed from these data.<\/p>\n<p>This section includes links to Pharmacosmos sponsored-publications. Information contained in these publications may include information that is inconsistent with the FDA approved use of product(s). Pharmacosmos does not recommend the use of its products in a manner that is inconsistent with FDA-approved labeling.<\/p>\n<p style=\"text-align: left;\"><!--StartFragment --><span class=\"cf0\">Note: Ferric derisomaltose is marketed as Monofer in some countries outside the US. The term ferric derisomaltose (FDI) has replaced iron isomaltoside (IIM).<\/span><!--EndFragment --><span style=\"font-size: xx-small;\">\u00a0<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;Features&#8221; _builder_version=&#8221;4.23.2&#8243; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;40px|0px|46px|0px||&#8221; da_disable_devices=&#8221;off|off|off&#8221; global_colors_info=&#8221;{}&#8221; da_is_popup=&#8221;off&#8221; da_exit_intent=&#8221;off&#8221; da_has_close=&#8221;on&#8221; da_alt_close=&#8221;off&#8221; da_dark_close=&#8221;off&#8221; da_not_modal=&#8221;on&#8221; da_is_singular=&#8221;off&#8221; da_with_loader=&#8221;off&#8221; da_has_shadow=&#8221;on&#8221;][et_pb_row make_equal=&#8221;on&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;-17px|auto|-16px|auto||&#8221; custom_padding=&#8221;19px||5px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.27.4&#8243; text_line_height=&#8221;1.8em&#8221; header_font=&#8221;||||||||&#8221; header_text_align=&#8221;center&#8221; header_text_color=&#8221;#000000&#8243; header_font_size=&#8221;20px&#8221; header_line_height=&#8221;0em&#8221; background_layout=&#8221;dark&#8221; custom_margin=&#8221;11px||11px|0px|true|false&#8221; custom_padding=&#8221;|||&#8221; header_font_size_tablet=&#8221;&#8221; header_font_size_phone=&#8221;&#8221; header_font_size_last_edited=&#8221;on|desktop&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h1 style=\"text-align: left;\">Ferric derisomaltose<\/h1>\n<p>[\/et_pb_text][et_pb_blurb icon_placement=&#8221;left&#8221; content_max_width=&#8221;1100px&#8221; _builder_version=&#8221;4.27.4&#8243; header_font=&#8221;|on|||&#8221; header_text_color=&#8221;#2e2545&#8243; header_line_height=&#8221;1.5em&#8221; body_font=&#8221;||||||||&#8221; body_text_color=&#8221;#131b68&#8243; body_font_size=&#8221;13px&#8221; body_line_height=&#8221;1.5em&#8221; background_color=&#8221;#ffffff&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; min_height=&#8221;20px&#8221; custom_margin=&#8221;-13px||7px|-15px|false|false&#8221; custom_padding=&#8221;17px||9px||false|false&#8221; animation_style=&#8221;zoom&#8221; animation_direction=&#8221;left&#8221; animation_intensity_zoom=&#8221;10%&#8221; animation_starting_opacity=&#8221;100%&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: left;\"><a href=\"https:\/\/pharmacosmosmedical.com\/staging\/1978\/wp-content\/uploads\/2024\/04\/Monoferric-Prescribing-Information.pdf\" target=\"_blank\" rel=\"noopener\">Prescribing Information<\/a><\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_3,1_3,1_3&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.27.4&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; custom_margin=&#8221;||||false|false&#8221; custom_css_main_element=&#8221;display: flex;||flex-direction: row;&#8221; global_colors_info=&#8221;{}&#8221; custom_css_main_element_tablet=&#8221;display: flex;||flex-direction: column;&#8221; custom_css_main_element_phone=&#8221;display: flex;||flex-direction: column;&#8221; custom_css_main_element_last_edited=&#8221;on|phone&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.23.3&#8243; custom_padding=&#8221;|||&#8221; box_shadow_style=&#8221;preset1&#8243; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_blurb icon_placement=&#8221;left&#8221; _builder_version=&#8221;4.23.3&#8243; header_font=&#8221;|on|||&#8221; header_text_color=&#8221;#2e2545&#8243; header_line_height=&#8221;1.5em&#8221; body_text_color=&#8221;#131B68&#8243; body_font_size=&#8221;16px&#8221; body_line_height=&#8221;1.5em&#8221; background_color=&#8221;#ffffff&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; custom_margin=&#8221;||16px||false|false&#8221; custom_padding=&#8221;20px|20px|20px|20px|true|true&#8221; animation_style=&#8221;zoom&#8221; animation_direction=&#8221;left&#8221; animation_intensity_zoom=&#8221;10%&#8221; animation_starting_opacity=&#8221;100%&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>August 2021 I Am J Cardiol<\/p>\n<p><strong>Safety and efficacy of intravenous ferric derisomaltose compared to iron sucrose for iron deficiency anemia in patients with chronic kidney disease with and without heart failure<\/strong><\/p>\n<p>Ambrosy AP, von Haehling S, Kalra PR, et al.<\/p>\n<p>[\/et_pb_blurb][et_pb_blurb icon_placement=&#8221;left&#8221; _builder_version=&#8221;4.23.3&#8243; header_font=&#8221;|on|||&#8221; 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box_shadow_style=&#8221;preset1&#8243; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_blurb icon_placement=&#8221;left&#8221; _builder_version=&#8221;4.23.3&#8243; header_font=&#8221;|on|||&#8221; header_text_color=&#8221;#2e2545&#8243; header_line_height=&#8221;1.5em&#8221; body_text_color=&#8221;#131b68&#8243; body_font_size=&#8221;16px&#8221; body_line_height=&#8221;1.5em&#8221; background_color=&#8221;#ffffff&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; custom_margin=&#8221;||-3px||false|false&#8221; custom_padding=&#8221;20px|20px|20px|20px|true|true&#8221; animation_style=&#8221;zoom&#8221; animation_direction=&#8221;left&#8221; animation_intensity_zoom=&#8221;10%&#8221; animation_starting_opacity=&#8221;100%&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>January 2021 I Nephrol Dial Transplant<br \/><strong><\/strong><\/p>\n<p><strong>Safety and efficacy of iron isomaltoside 1000\/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial<\/strong><\/p>\n<p>Bhandari S, Kalra PA, Berkowitz M, et al.<\/p>\n<p>[\/et_pb_blurb][et_pb_blurb icon_placement=&#8221;left&#8221; content_max_width=&#8221;1100px&#8221; _builder_version=&#8221;4.27.4&#8243; header_font=&#8221;|on|||&#8221; header_text_color=&#8221;#2e2545&#8243; header_line_height=&#8221;1.5em&#8221; body_text_color=&#8221;#131b68&#8243; body_font_size=&#8221;16px&#8221; body_line_height=&#8221;1.5em&#8221; background_color=&#8221;#ffffff&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; min_height=&#8221;20px&#8221; custom_margin=&#8221;-16px||7px||false|false&#8221; custom_padding=&#8221;17px||9px||false|false&#8221; animation_style=&#8221;zoom&#8221; animation_direction=&#8221;left&#8221; animation_intensity_zoom=&#8221;10%&#8221; animation_starting_opacity=&#8221;100%&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\"><a href=\"#pop-2\"><strong>View Publication<\/strong><\/a><\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.23.3&#8243; custom_padding=&#8221;|||&#8221; box_shadow_style=&#8221;preset1&#8243; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_blurb icon_placement=&#8221;left&#8221; _builder_version=&#8221;4.23.3&#8243; header_font=&#8221;|on|||&#8221; header_text_color=&#8221;#2e2545&#8243; header_line_height=&#8221;1.5em&#8221; body_text_color=&#8221;#131B68&#8243; body_font_size=&#8221;16px&#8221; body_line_height=&#8221;1.5em&#8221; background_color=&#8221;#ffffff&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; min_height=&#8221;295px&#8221; custom_margin=&#8221;||-78px||false|false&#8221; custom_padding=&#8221;20px|20px|20px|20px|true|true&#8221; animation_style=&#8221;zoom&#8221; animation_direction=&#8221;left&#8221; animation_intensity_zoom=&#8221;10%&#8221; animation_starting_opacity=&#8221;100%&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>January 2021 I Am J Hematol<\/p>\n<p><strong>Safety of ferric derisomaltose and iron sucrose in patients with iron deficiency anemia: The FERWON-IDA\/NEPHRO trials<\/strong><\/p>\n<p>Wolf M, Auerbach M, Kalra PA et al.<\/p>\n<p>[\/et_pb_blurb][et_pb_blurb icon_placement=&#8221;left&#8221; _builder_version=&#8221;4.23.3&#8243; header_font=&#8221;|on|||&#8221; header_text_color=&#8221;#2e2545&#8243; header_line_height=&#8221;1.5em&#8221; body_text_color=&#8221;#131B68&#8243; body_font_size=&#8221;16px&#8221; body_line_height=&#8221;1.5em&#8221; background_color=&#8221;#ffffff&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; min_height=&#8221;6px&#8221; custom_margin=&#8221;||5px||false|false&#8221; custom_padding=&#8221;69px|20px|0px|20px|false|true&#8221; custom_padding_tablet=&#8221;0px||||false|true&#8221; custom_padding_phone=&#8221;0px||||false|true&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; animation_style=&#8221;zoom&#8221; animation_direction=&#8221;left&#8221; animation_intensity_zoom=&#8221;10%&#8221; animation_starting_opacity=&#8221;100%&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\"><strong><\/strong><\/p>\n<p style=\"text-align: center;\"><strong><\/strong><\/p>\n<p style=\"text-align: center;\"><strong><\/strong><\/p>\n<p style=\"text-align: center;\"><span style=\"font-size: 16px;\"><\/span><a href=\"#pop-5\" target=\"_blank\" rel=\"noopener\" style=\"font-size: 16px;\"><strong>View Publication<\/strong><\/a><strong><\/strong><\/p>\n<p style=\"text-align: center;\"><strong><\/strong><\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_3,1_3,1_3&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.27.4&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; custom_margin=&#8221;||||false|false&#8221; custom_css_main_element=&#8221;display: flex;||flex-direction: row;&#8221; global_colors_info=&#8221;{}&#8221; custom_css_main_element_tablet=&#8221;display: flex;||flex-direction: column;&#8221; custom_css_main_element_phone=&#8221;display: flex;||flex-direction: column;&#8221; custom_css_main_element_last_edited=&#8221;on|phone&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.23.3&#8243; custom_padding=&#8221;|||&#8221; box_shadow_style=&#8221;preset1&#8243; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_blurb icon_placement=&#8221;left&#8221; _builder_version=&#8221;4.27.4&#8243; header_font=&#8221;|on|||&#8221; header_text_color=&#8221;#2e2545&#8243; header_line_height=&#8221;1.5em&#8221; body_text_color=&#8221;#131B68&#8243; body_font_size=&#8221;16px&#8221; body_line_height=&#8221;1.5em&#8221; background_color=&#8221;#ffffff&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; custom_margin=&#8221;||52px||false|false&#8221; custom_padding=&#8221;20px|20px|20px|20px|true|true&#8221; animation_style=&#8221;zoom&#8221; animation_direction=&#8221;left&#8221; animation_intensity_zoom=&#8221;10%&#8221; animation_starting_opacity=&#8221;100%&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>October 2020 I Am J Hematol<\/p>\n<p><strong>A 6 month extension trial evaluating safety and efficacy of ferric derisomaltose in patients with iron deficiency anemia: The FERWON-EXT trial<\/strong><\/p>\n<p>Achebe MM, Glaspy J, Kalra PA, et al.<\/p>\n<p>[\/et_pb_blurb][et_pb_blurb icon_placement=&#8221;left&#8221; _builder_version=&#8221;4.27.4&#8243; header_font=&#8221;|on|||&#8221; header_text_color=&#8221;#2e2545&#8243; header_line_height=&#8221;1.5em&#8221; body_text_color=&#8221;#131B68&#8243; body_font_size=&#8221;16px&#8221; body_line_height=&#8221;1.5em&#8221; background_color=&#8221;#ffffff&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; custom_margin=&#8221;||||false|false&#8221; custom_padding=&#8221;|20px|20px|20px|false|true&#8221; animation_style=&#8221;zoom&#8221; animation_direction=&#8221;left&#8221; animation_intensity_zoom=&#8221;10%&#8221; animation_starting_opacity=&#8221;100%&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\"><strong><\/strong><\/p>\n<p style=\"text-align: center;\"><strong><a href=\"#pop-4\" target=\"_blank\" rel=\"noopener\">View Publication<\/a><\/strong><\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.23.3&#8243; custom_padding=&#8221;|||&#8221; box_shadow_style=&#8221;preset1&#8243; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_blurb _builder_version=&#8221;4.27.4&#8243; body_text_color=&#8221;#131B68&#8243; body_font_size=&#8221;16px&#8221; body_line_height=&#8221;1.5em&#8221; custom_margin=&#8221;||42px||false|false&#8221; custom_padding=&#8221;20px|20px|20px|20px|true|true&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>September 2019 I Am J Hematol<br \/><strong><\/strong><\/p>\n<p><strong>A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial<\/strong><\/p>\n<p>Auerbach M, Henry D, Derman RJ, et al.<\/p>\n<p>[\/et_pb_blurb][et_pb_blurb _builder_version=&#8221;4.27.4&#8243; body_text_color=&#8221;#131B68&#8243; body_font_size=&#8221;16px&#8221; body_line_height=&#8221;1.5em&#8221; min_height=&#8221;55px&#8221; custom_margin=&#8221;-7px|||||&#8221; custom_padding=&#8221;19px||0px||false|false&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\">\u00a0\u00a0<a href=\"#pop\"><strong>View Publication<\/strong><\/a><\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; 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