This will be a randomized clinical trial. Enrolled subjects will be randomized (1:1) into two study arms to receive either daily (Group 1) or alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill.

Start Date01 Dec 2024

Sponsor / Collaborator

Southern Illinois University Carbondale

CTR20243192

/ RecruitingPhase 1/2

一项评价纳米炭铁混悬注射液（CNSI-Fe）瘤内注射、多次给药在晚期实体瘤受试者中的安全性、耐受性、药代动力学特征和初步有效性的Ib/IIa期临床研究

[Translation] A Phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of intratumoral injection and multiple doses of nanocarbon iron suspension injection (CNSI-Fe) in subjects with advanced solid tumors

Ib期：主要目的：评估瘤内注射不同剂量、多次给药CNSI-Fe在晚期实体瘤受试者中的安全性和耐受性。次要目的：评估瘤内注射不同剂量、多次给药CNSI-Fe在晚期实体瘤受试者中的PK特征；评估瘤内注射不同剂量、多次给药CNSI-Fe在晚期实体瘤受试者中目标病灶的抗肿瘤有效性。 IIa期：主要目的：在目标晚期实体瘤队列中，评价CNSI-Fe瘤内注射、多次给药的抗肿瘤活性。次要目的： ·评估CNSI-Fe瘤内注射、多次给药治疗目标晚期实体瘤受试者的安全性和耐受性； ·进一步评估CNSI-Fe瘤内注射、多次给药治疗目标晚期实体瘤受试者的总体抗肿瘤有效性； ·进一步评估CNSI-Fe瘤内注射、多次给药治疗目标晚期实体瘤受试者中目标病灶的抗肿瘤有效性。

[Translation]

Phase Ib: Primary purpose: To evaluate the safety and tolerability of CNSI-Fe injected intratumorally at different doses and multiple administrations in subjects with advanced solid tumors. Secondary purpose: To evaluate the PK characteristics of CNSI-Fe injected intratumorally at different doses and multiple administrations in subjects with advanced solid tumors; To evaluate the anti-tumor efficacy of CNSI-Fe injected intratumorally at different doses and multiple administrations in target lesions in subjects with advanced solid tumors. Phase IIa: Primary purpose: To evaluate the anti-tumor activity of CNSI-Fe injected intratumorally at multiple administrations in the target advanced solid tumor cohort. Secondary purposes: ·To evaluate the safety and tolerability of CNSI-Fe injected intratumorally at multiple administrations in the treatment of target advanced solid tumor subjects; ·To further evaluate the overall anti-tumor efficacy of CNSI-Fe injected intratumorally at multiple administrations in the treatment of target advanced solid tumor subjects; ·To further evaluate the anti-tumor efficacy of CNSI-Fe injected intratumorally at multiple administrations in the treatment of target lesions in the treatment of target advanced solid tumor subjects.

Start Date01 Nov 2024

Sponsor / Collaborator

Sichuan Yingrui Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Ferrous sulfate

100 Translational Medicine associated with Ferrous sulfate

100 Patents (Medical) associated with Ferrous sulfate

1,989

Literatures (Medical) associated with Ferrous sulfate

01 Jan 2025·Journal of Environmental Management

Enhanced effect of ferrous sulfate on nitrogen retention and PBAT degradation during co-composting by combing with biochar-loaded FN1 bacterial composites

Article

Author: Wang, Linshan ; Yang, Shen ; Hu, Run ; Zhang, Hong ; Qi, Yanjiao ; Wang, Zifan ; Cao, Long ; Song, Lisha ; Gao, Jiazhi ; Liu, Qiang

The treatment of biodegradable plastics through composting has garnered increasing attention. This study aimed to investigate the effects of Biochar FN1 bacteria and ferrous sulfate on nitrogen retention, greenhouse gas emissions, and degradable plastics during composting and to elucidate their synergistic mechanisms on microbial communities. Compared with the control, applying biochar-loaded FN1 bacteria composites combined with Ferrous sulfate (SGC) markedly accelerated organic matter degradation and reduced cumulative CO₂ and NH₃ emissions. The synergistic interaction between the composites and Ferrous sulfate significantly enhanced NH₄⁺-N levels in the thermophilic phase and NO₃^--N levels in the cooling phase, ultimately decreasing nitrogen loss by 14.9% (P < 0.05) and increasing the seed germination index (GI) by 22.5% (P < 0.05). Additionally, PBAT plastic degradation was improved by 31.6% (P < 0.05). The SGC treatment also altered the richness and diversity of the bacterial community in both the compost and the PBAT plastic sphere, particularly affecting Sphingobacterium, Pseudomonas, and Flavobacterium at the genus level. Symbiotic network analysis and Redundancy Analysis revealed that these functional degradation bacteria were significantly positively correlated with NO₃^--N levels and PBAT degradation. Furthermore, structural equation modelling indicated a positive relationship between PBAT degradation rate and composting temperature (r = 0.69, p < 0.05). The findings suggested that Fe²⁺ not only enhanced the FN1 activity but also promoted PBAT degradation by increasing ·OH content on the PBAT plastic sphere. Overall, the combined use of biochar-loaded FN1 bacteria and Ferrous sulfate effectively supports nitrogen retention and plastic degradation during composting.

01 Jan 2025·Journal of Clinical Sleep Medicine

Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline

Review

Author: Shelgikar, Anita V. ; Kazmi, Uzma ; Sharon, Denise ; Falck-Ytter, Yngve ; Koo, Brian B. ; DelRosso, Lourdes M. ; Trotti, Lynn Marie ; Berkowski, J. Andrew ; Walters, Arthur S. ; Zak, Rochelle S. ; Winkelman, John W. ; Scharf, Matthew T.

INTRODUCTIONThis guideline establishes clinical practice recommendations for treatment of restless legs syndrome (RLS) and periodic limb movement disorder (PLMD) in adults and pediatric patients.METHODSThe American Academy of Sleep Medicine (AASM) commissioned a task force of experts in sleep medicine to develop recommendations and assign strengths based on a systematic review of the literature and an assessment of the evidence using the grading of recommendations assessment, development, and evaluation methodology. The task force provided a summary of the relevant literature and the certainty of evidence, the balance of benefits and harms, patient values and preferences, and resource use considerations that support the recommendations. The AASM Board of Directors approved the final recommendations.GOOD PRACTICE STATEMENTThe following good practice statement is based on expert consensus, and its implementation is necessary for the appropriate and effective management of patients with RLS.1. In all patients with clinically significant RLS, clinicians should regularly test serum iron studies including ferritin and transferrin saturation (calculated from iron and total iron binding capacity). Testing should ideally be administered in the morning avoiding all iron-containing supplements and foods at least 24 hours prior to blood draw. Analysis of iron studies greatly influences the decision to use oral or intravenous (IV) iron treatment. Consensus guidelines, which have not been empirically tested, suggest that supplementation of iron in adults with RLS should be instituted with oral or IV iron if serum ferritin ≤ 75 ng/mL or transferrin saturation < 20%, and only with IV iron if serum ferritin is between 75 and 100 ng/mL. In children, supplementation of iron should be instituted for serum ferritin < 50 ng/mL with oral or IV formulations. These iron supplementation guidelines are different than for the general population.2. The first step in the management of RLS should be addressing exacerbating factors, such as alcohol, caffeine, antihistaminergic, serotonergic, antidopaminergic medications, and untreated obstructive sleep apnea.3. RLS is common in pregnancy; prescribers should consider the pregnancy-specific safety profile of each treatment being considered.RECOMMENDATIONSThe following recommendations are intended as a guide for clinicians in choosing a specific treatment for RLS and PLMD in adults and children. Each recommendation statement is assigned a strength ("strong" or "conditional"). A "strong" recommendation (ie, "We recommend…") is one that clinicians should follow under most circumstances. The recommendations listed below are ranked in the order of strength of recommendations and grouped by class of treatments within each PICO (Patient, Intervention, Comparator, Outcome) question. Some recommendations include remarks that provide additional context to guide clinicians with implementation of this recommendation.ADULTS WITH RLS1. In adults with RLS, the AASM recommends the use of gabapentin enacarbil over no gabapentin enacarbil (strong recommendation, moderate certainty of evidence).2. In adults with RLS, the AASM recommends the use of gabapentin over no gabapentin (strong recommendation, moderate certainty of evidence).3. In adults with RLS, the AASM recommends the use of pregabalin over no pregabalin (strong recommendation, moderate certainty of evidence).4. In adults with RLS, the AASM recommends the use of IV ferric carboxymaltose over no IV ferric carboxymaltose in patients with appropriate iron status (see good practice statement for iron parameters) (strong recommendation, moderate certainty of evidence).5. In adults with RLS, the AASM suggests the use of IV low molecular weight iron dextran over no IV low molecular weight iron dextran in patients with appropriate iron status (see good practice statement for iron parameters) (conditional recommendation, very low certainty of evidence).6. In adults with RLS, the AASM suggests the use of IV ferumoxytol over no IV ferumoxytol in patients with appropriate iron status (see good practice statement for iron parameters) (conditional recommendation, very low certainty of evidence).7. In adults with RLS, the AASM suggests the use of ferrous sulfate over no ferrous sulfate in patients with appropriate iron status (see good practice statement for iron parameters) (conditional recommendation, moderate certainty of evidence).8. In adults with RLS, the AASM suggests the use of dipyridamole over no dipyridamole (conditional recommendation, low certainty of evidence).9. In adults with RLS, the AASM suggests the use of extended-release oxycodone and other opioids over no opioids (conditional recommendation, moderate certainty of evidence).10. In adults with RLS, the AASM suggests the use of bilateral high-frequency peroneal nerve stimulation over no peroneal nerve stimulation (conditional recommendation, moderate certainty of evidence).11. In adults with RLS, the AASM suggests against the standard use of levodopa (conditional recommendation, very low certainty of evidence).Remarks: levodopa may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).12. In adults with RLS, the AASM suggests against the standard use of pramipexole (conditional recommendation, moderate certainty of evidence).Remarks: pramipexole may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).13. In adults with RLS, the AASM suggests against the standard use of transdermal rotigotine (conditional recommendation, low certainty of evidence).Remarks: transdermal rotigotine may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).14. In adults with RLS, the AASM suggests against the standard use of ropinirole (conditional recommendation, moderate certainty of evidence).Remarks: ropinirole may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).15. In adults with RLS, the AASM suggests against the use of bupropion for the treatment of RLS (conditional recommendation, moderate certainty of evidence).16. In adults with RLS, the AASM suggests against the use of carbamazepine (conditional recommendation, low certainty of evidence).17. In adults with RLS, the AASM suggests against the use of clonazepam (conditional recommendation, very low certainty of evidence).18. In adults with RLS, the AASM suggests against the use of valerian (conditional recommendation, very low certainty of evidence).19. In adults with RLS, the AASM suggests against the use of valproic acid (conditional recommendation, low certainty of evidence).20. In adults with RLS, the AASM recommends against the use of cabergoline (strong recommendation, moderate certainty of evidence).SPECIAL ADULT POPULATIONS WITH RLS21. In adults with RLS and end-stage renal disease (ESRD), the AASM suggests the use of gabapentin over no gabapentin (conditional recommendation, very low certainty of evidence).22. In adults with RLS and ESRD, the AASM suggests the use of IV iron sucrose over no IV iron sucrose in patients with ferritin < 200 ng/mL and transferrin saturation < 20% (conditional recommendation, moderate certainty of evidence).23. In adults with RLS and ESRD, the AASM suggests the use of vitamin C over no vitamin C (conditional recommendation, low certainty of evidence).24. In adults with RLS and ESRD, the AASM suggests against the standard use of levodopa (conditional recommendation, low certainty of evidence).Remarks: levodopa may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).25. In adults with RLS and ESRD, the AASM suggests against the standard use of rotigotine (conditional recommendation, very low certainty of evidence).Remarks: rotigotine may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).ADULTS WITH PLMD26. In adults with PLMD, the AASM suggests against the use of triazolam (conditional recommendation, very low certainty of evidence).27. In adults with PLMD, the AASM suggests against the use of valproic acid (conditional recommendation, very low certainty of evidence).CHILDREN WITH RLS28. In children with RLS, the AASM suggests the use of ferrous sulfate over no ferrous sulfate in patients with appropriate iron status (see good practice statement for iron parameters) (conditional recommendation, very low certainty of evidence).CITATIONWinkelman JW, Berkowski JA, DelRosso LM, et al. Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2025;21(1):137-152.

01 Jan 2025·International Journal of Food Microbiology

Iron fortification modifies the microbial community structure and metabolome of a model surface-ripened cheese

Article

Author: Shoukat, Mahtab ; Sarthou, Anne-Sophie ; Bonnarme, Pascal ; Peron, Anne-Claire ; Swennen, Dominique ; Danel, Alice ; Hervé, Vincent ; Dugat-Bony, Eric

Iron is a vital micronutrient for nearly all microorganisms, serving as a co-factor in critical metabolic pathways. However, cheese is an iron-restricted environment. Furthermore, it has been demonstrated that iron represents a growth-limiting factor for many microorganisms involved in cheese ripening and that this element is central to many microbial interactions occurring in this ecosystem. This study explores the impact of iron fortification on the growth and activity of a reduced microbial community composed of nine strains representative of the microbial community of surface-ripened cheeses. Three different iron compounds (ferrous sulfate, ferric chloride, ferric citrate) were used at three different concentrations, i.e., 18, 36, and 72 μM, to fortify cheese curd after inoculation with the consortium. This treatment significantly enhanced the growth of certain cheese-ripening bacteria in curd, resulting in substantial changes in the volatilome and metabolome profiles. These observations were dose-dependent, with more pronounced effects detected with higher iron concentrations. No statistically significant difference was observed in the microbial composition based on the iron compounds used for fortification, but this factor had an impact on the volatilome and amino acids profile. These findings highlight the importance of iron availability for the behavior of cheese microbial communities. They also open novel perspectives on cheesemakers' use of iron fortification to control microbial growth and improve cheese quality.

News (Medical) associated with Ferrous sulfate

05 Jun 2023

·www.biospace.com

INJECTAFER® Approved in the U.S. for the Treatment of Iron Deficiency in Adult Patients with Heart Failure

INJECTAFER is now the first and only intravenous (IV) iron replacement therapy indicated for adult patients with heart failure who have iron deficiency BASKING RIDGE, N.J. & SHIRLEY, N.Y.--(BUSINESS WIRE)-- Daiichi Sankyo Inc. and American Regent, Inc., a Daiichi Sankyo Group company, today announced that the U.S. Food and Drug Administration (FDA) approved INJECTAFER® (ferric carboxymaltose injection) for the treatment of iron deficiency in adult patients with heart failure categorized as New York Heart Association class II/III to improve exercise capacity.1 “This new indication for INJECTAFER marks the first and only FDA approval of an intravenous iron replacement therapy for adult patients with heart failure, a progressive and chronic disease. Approximately 2.8 million U.S. adults are impacted by heart failure with iron deficiency or iron deficiency anemia, which can affect their daily lives and activities,”1-10 said Ravi Tayi, MD, MPH, Chief Medical Officer at American Regent, Inc. “INJECTAFER is the most extensively studied intravenous iron and this latest approval continues to build on the effective and proven use of INJECTAFER for adult and pediatric patients with iron deficiency anemia, and now for adult patients with heart failure who have iron deficiency.”11 The New York Heart Association Functional Classification classifies patients’ heart failure based on the severity of their symptoms. Patients who have a slight or marked limitation of their physical activity due to fatigue, palpitation and/or dyspnea are considered to have class II or class III heart failure, respectively.12 The approval was supported by INJECTAFER data from a randomized controlled study, CONFIRM-HF (NCT01453608), that evaluated the efficacy and safety of INJECTAFER in adult patients with chronic heart failure and iron deficiency. Treatment with INJECTAFER significantly improved exercise capacity compared to placebo in iron deficient patients with heart failure.13 The safety results from the trial were generally consistent with the known safety pro INJECTAFER. The most common treatment emergent adverse events (TEAEs) observed with INJECTAFER were headache, nausea, hypertension, injection site reactions, hypophosphatemia, and dizziness.14 INJECTAFER has been studied in more than 40 clinical trials that included over 8,800 patients worldwide.15 INJECTAFER has been approved in 86 countries since initial European Union approval in 2007 and is the most extensively studied IV iron.11,16 Daiichi Sankyo is committed to ensuring that patients in the U.S. who are prescribed INJECTAFER can access the medication and receive necessary financial support. Provider and patient support related to access, reimbursement and distribution for INJECTAFER in the U.S. will be accessible through Daiichi Sankyo Access Central by visiting or calling 1-866-4-DSI-NOW (1-866-437-4669). About INJECTAFER INJECTAFER (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency in adult patients with heart failure; iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron; and adult patients with IDA who have non-dialysis dependent chronic kidney disease.1 For patients weighing 50 kg (110 lbs) or more, it is given intravenously (into the vein) by a healthcare provider in two doses of 750 mg each at least seven days apart.1 For patients weighing less than 50 kg, each of the two doses is administered as 15 mg/kg body weight separated by at least seven days.1 INJECTAFER dosing for iron deficiency in adult patients with heart failure and New York Heart Association class II/III is based on patient weight (154.3 lbs) and hemoglobin level (ranges from <10 to 14-15 grams per deciliter (g/dl), starting at a single 500 mg dose up to two 1000 mg doses separated by six weeks). A maintenance dose of 500 mg may be administered at 12, 24 and 36 weeks for certain patients based on their serum ferritin levels and transferrin saturation value.1 Injectafer is manufactured and marketed under the name of Ferinject® (Ferric Carboxymaltose) by CSL Vifor outside of North America. CSL Vifor is a global partner of choice for innovative therapies in iron deficiency, dialysis and nephrology & rare disease. CSL Vifor specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. U.S. Important Safety Information for INJECTAFER INDICATIONS Injectafer® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron, and in adult patients who have non-dialysis dependent chronic kidney disease. Injectafer is also indicated for iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Injectafer is contraindicated in patients with hypersensitivity to Injectafer or any of its inactive components. WARNINGS AND PRECAUTIONS Symptomatic Hypophosphatemia Symptomatic hypophosphatemia with serious outcomes including osteomalacia and fractures requiring clinical intervention has been reported in patients treated with Injectafer in the post-marketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. However, symptomatic hypophosphatemia has been reported after one dose. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, inflammatory bowel disease, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency, and malnutrition. In most cases, hypophosphatemia resolved within three months. Correct pre-existing hypophosphatemia prior to initiating therapy with Injectafer. Monitor serum phosphate levels in patients at risk for chronic low serum phosphate. Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a second course of therapy within three months. Treat hypophosphatemia as medically indicated. Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Injectafer. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Injectafer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Injectafer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but were not limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1775) of these subjects. Hypertension In clinical studies, hypertension was reported in 4% (67/1775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects in these two clinical trials. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Injectafer administration. Laboratory Test Alterations In the 24 hours following administration of Injectafer, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Injectafer. ADVERSE REACTIONS Adults In two randomized clinical studies [Studies 1 and 2], a total of 1775 patients were exposed to Injectafer, 15 mg/kg of body weight, up to a maximum single dose of 750 mg of iron on two occasions, separated by at least 7 days, up to a cumulative dose of 1500 mg of iron. Adverse reactions reported by >2% of Injectafer-treated patients were nausea (7.2%); hypertension (4%); flushing (4%); injection site reactions (3%); erythema (3%); hypophosphatemia (2.1%); and dizziness (2.1%). Pediatric The safety of Injectafer in pediatric patients was evaluated in Study 3. Study 3 was a randomized, active-controlled study in which 40 patients (1 to 12 years of age: 10 patients, 12 to 17 years of age: 30 patients) received Injectafer 15 mg/kg to a maximum single dose of 750 mg (whichever was smaller) on Days 0 and 7 for a maximum total dose of 1500 mg; 38 patients evaluable for safety in the control arm received an age-dependent formulation of oral ferrous sulfate for 28 days. The median age of patients who received Injectafer was 14.5 years (range, 1-17); 83% were female; 88% White and 13% Black. The most common adverse reactions (≥4%) were hypophosphatemia (13%), injection site reactions (8%), rash (8%), headache (5%), and vomiting (5%). Patients with Iron Deficiency and Heart Failure The safety of Injectafer was evaluated in adult patients with iron deficiency and heart failure in randomized controlled trials FAIR-HF (NCT00520780), CONFIRM-HF (NCT01453608) and AFFIRM-AHF (NCT02937454) in which 1016 patients received Injectafer versus 857 received placebo. The overall safety pro Injectafer was consistent across the studied indications. Post-Marketing Experience The following adverse reactions have been identified during post approval use of Injectafer. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been reported from the post-marketing spontaneous reports with Injectafer: cardiac disorders: tachycardia; general disorders and administration site conditions: chest discomfort, chills, pyrexia; metabolism and nutrition disorders: hypophosphatemia; musculoskeletal and connective tissue disorders: arthralgia, back pain, hypophosphatemic osteomalacia; nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia. CLINICAL CONSIDERATIONS IN PREGNANCY Untreated IDA in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as Injectafer) which may cause fetal bradycardia, especially during the second and third trimester. You are encouraged to report Adverse Drug Events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting or calling 1-800-FDA-1088. Please see accompanying full Prescribing Information and Medication Guide. About Daiichi Sankyo Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 17,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.” For more information, please visit: . About American Regent, Inc. American Regent, Inc., a Daiichi Sankyo Group company, is an industry leading injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing and supplying quality generic and branded injectables for healthcare providers. For more than 20 years, we have been a leader in IV iron therapy. American Regent is committed to US-based manufacturing. To that end, over the last several years, we have made significant investments in expanding and modernizing our manufacturing facilities in Ohio and New York. This expansion will nearly double our capacity and allow us to better serve our customers now and in the future. Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need. __________________ 1 Injectafer [package insert]. Shirley, NY: American Regent, Inc.; May 2023. 2 MonoFerric [package insert]. Morristown, NJ: Pharmacosmos Therapeutics Inc.; February 2022. 3 Venofer [package insert]. Shirly, NY: American Regent, Inc.; October 2020. 4 INFeD [package insert]. Madison, NJ: Allergan; September 2021. 5 Ferrlecit [package insert]. Bridgewater, NJ: sanofi-aventis US LLC; March 2021. 6 Feraheme [package insert]. Waltham, MA: AMAG Pharmaceuticals, Inc.; June 2022. 7 Virani S, Alonso A, Aparicio H, et al. Heart Disease and Stroke Statistics – 2020 Update. Circulation. 2020; 141(9): e139-e596. 8 Ebner N, von Haehling S. Why is iron deficiency recognised as an important comorbidity in heart failure? Card Fail Rev. 2019;5(3):173-5. 9 Anand IS, Gupta P. Anemia and Iron Deficiency in Heart Failure: Current Concepts and Emerging Therapies. Circulation. 2018 Jul 3;138(1):80-98. 10 Data on file. Injectafer Heart Failure Demand Assessment in the Outpatient Setting Working Meeting; March 2022. 11 Data on file. Injectafer Studies. Daiichi Sankyo Inc., Basking Ridge, NJ. 12 Classes of Heart Failure. American Heart Association. May 2017. 13 Ponikowski P, van Veldhuisen DJ, Comin-Colet J, et al. Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency. Eur Heart J. 2015 Mar 14;36(11):657-68. 14Data on file. Module 5 (Integrated Summary of Safety for FCM). Daiichi Sankyo Inc., Basking Ridge, NJ. 15Data on file. PSUR (Periodic Safety Update Report), January 2017. Luitpold Pharmaceuticals, Inc., Shirley, NY. 16 Vifor Pharma Annual Report. . Accessed February 2023.

Clinical ResultDrug ApprovalAHA

100 Deals associated with Ferrous sulfate

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Anemia, Iron-Deficiency	US	Redpharm Drug	01 Jan 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04594070 (CTgov)	Phase 4	Iron deficiency anemia of pregnancy	14	Ferrous sulfate (Daily Iron Supplementation)	eiwutdnnba(jzrvygncwk) = qjgegwyoxd cmyyqjrrmg (lkqcjepbxz, cflavcynsa - rnxciuqiac) View more	-	24 Jun 2024
				Ferrous sulfate (Alternate Day Iron Supplementation)	eiwutdnnba(jzrvygncwk) = vugowrdcok cmyyqjrrmg (lkqcjepbxz, fykvuabwez - xhcunpzpft) View more
NCT04610827 (CTgov)	Phase 4	Iron deficiency \| Restless Legs Syndrome \| Nocturnal Myoclonus Syndrome	6	Ferrous sulfate (Ferrous Sulfate Daily)	zowaekczkw(sqhdqozjkx) = sghfuxergd vmecahhimc (smdthvught, lanrdxtuen - ztjdgcbolf) View more	-	22 May 2024
				Ferrous sulfate (Ferrous Sulfate Twice Daily)	(lebqgmdvcy) = qrgwqopnra liucucsrrb (ebkvxqxsmm, hnoufwsvds - mqchaleqwy) View more
NCT02499354 (IVOR-IDA, CTgov)	Phase 2	Restless Legs Syndrome \| Anemia, Iron-Deficiency	100	Ferrous sulfate (Oral Iron)	yugincgzos(gjpirilvte) = wtnytdiith mdjdgizqem (xthjrgfeal, xvorzwmzik - kjsnjjuobe) View more	-	15 Aug 2023
				Ferumoxytol intravenous (IV Iron)	yugincgzos(gjpirilvte) = troaovfwse mdjdgizqem (xthjrgfeal, wbqirlquxc - xgjzrlzusg) View more
NCT04371536 (CTgov)	Phase 3	Iron deficiency \| Anemia, Iron-Deficiency	1	Ferrous Sulfate (Arm A: Oral Iron Therapy)	jhpciugjst(stbhkulhkl) = wgzturkjxe ebyjgyyber (zwndnymsjr, vynbpjjlze - ltupkaecfy) View more	-	06 May 2023
				IRONCHILD+Ferrous Sulfate (Arm B: Oral Iron Therapy Plus IRONCHILD Web-based Intervention)	jhpciugjst(stbhkulhkl) = xwypwtmzmz ebyjgyyber (zwndnymsjr, kieoiyhzjf - xmicxbapan) View more
NCT03523117 (CTgov)	Phase 3	Anemia, Iron-Deficiency	79	Ferric carboxymaltose (Ferric Caroboxymaltose)	iazvhwuarw(orvaxisluh) = ygutgkulkz zqgxayfmfd (yyxbijmxam, rzfcokhdux - ckppipchja) View more	-	22 Jun 2022
				Ferrous Sulfate (Oral Ferrous Sulfate)	iazvhwuarw(orvaxisluh) = rwzgrfnasg zqgxayfmfd (yyxbijmxam, odgltxrirx - mpxqcxcgml) View more
NCT02998697 (Pubmed \| Glob Heart)	Phase 2/3	Anemia, Iron-Deficiency	54	Oral Ferrous Sulphate	gbgbdhswcf(dbcxoruich) = ozzbvmbfad tvxzydzyvy (xsahygfqxf )	-	01 Jan 2022
				Placebo	gbgbdhswcf(dbcxoruich) = wemgszkfqq tvxzydzyvy (xsahygfqxf )
NCT02086968 (CTgov)	Phase 4	Anemia, Iron-Deficiency \| Inflammatory Bowel Diseases	198	Injectafer (Injectafer)	jploytkzoj(ivavtbgshp) = wxixqtdusd smpvgozobk (ixiulmqiai, laeogcocce - rmmkctpeuk) View more	-	17 Sep 2020
				Ferrous Sulfate tablets (Ferrous Sulfate Tablets)	jploytkzoj(ivavtbgshp) = aguloyjpnl smpvgozobk (ixiulmqiai, gjehvjqifs - gvwqtqutiy) View more
NCT00450177 (CTgov)	Phase 2	Anemia \| Critical Illness \| Infectious Diseases	200	Ferrous Sulfate (Iron Group)	foabdorsxe(tiuetpcwoq) = vqcifccxwh kqhfsbpjlc (acwbsobhub, wvuoowwnvj - pxwmzpwlno) View more	-	08 Jul 2019
				Placebo Oral Tablet (Placebo Group)	foabdorsxe(tiuetpcwoq) = bombgwnueg kqhfsbpjlc (acwbsobhub, oujigwwmos - eiataeppqu) View more
EHA2019	Not Applicable	-	36	Iron Sulphate	dryslnltht(jaghrmtdqa) = howznyddwr zydlnyyegf (ofdwuiysmp )	-	16 May 2019
				Sucrosomial® Iron	dryslnltht(jaghrmtdqa) = dafwqywgsx zydlnyyegf (ofdwuiysmp )
SUN-549 (ENDO2019)	Not Applicable	-	-	L-T4 25 mcg/d	mcqmyxzbgf(uhacyhvvll) = ppcuddhhzr qtqhwwxfrj (lolvbvnivo ) View more	-	30 Apr 2019
				L-T4 150-175 mcg/d	mcqmyxzbgf(uhacyhvvll) = domyrklvvn qtqhwwxfrj (lolvbvnivo ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Ferrous sulfate

Overview

Basic Info

Structure/Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation