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Chemistry

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Also known as: 33725-54-1, Iron (iii) maltol, Ferric maltol [inn], Ferric maltol [usan], St10, Ma10qyf1z0
Molecular Formula
C18H15FeO9
Molecular Weight
431.2  g/mol
InChI Key
AHPWLYJHTFAWKI-UHFFFAOYSA-K
FDA UNII
MA10QYF1Z0

Ferric Maltol
Ferric maltol is an iron(III) atom complexed with 3 maltol molecules to increase the bioavailability compared to iron(II), without depositing it in the duodenum as insoluble ferric hydroxide and phosphate. Ferric maltol has been described in literature since at least the late 1980s as a potential treatment for iron deficiency. Ferric maltol was granted FDA Approval on 25 July 2019.
1 2D Structure

Ferric Maltol

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
iron(3+);2-methyl-4-oxopyran-3-olate
2.1.2 InChI
InChI=1S/3C6H6O3.Fe/c3*1-4-6(8)5(7)2-3-9-4;/h3*2-3,8H,1H3;/q;;;+3/p-3
2.1.3 InChI Key
AHPWLYJHTFAWKI-UHFFFAOYSA-K
2.1.4 Canonical SMILES
CC1=C(C(=O)C=CO1)[O-].CC1=C(C(=O)C=CO1)[O-].CC1=C(C(=O)C=CO1)[O-].[Fe+3]
2.2 Other Identifiers
2.2.1 UNII
MA10QYF1Z0
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Accrufer

2. Iron (iii) Maltol

3. Iron(3+) Tris(2-methyl-4-oxo-4h-pyran-3-olate)

2.3.2 Depositor-Supplied Synonyms

1. 33725-54-1

2. Iron (iii) Maltol

3. Ferric Maltol [inn]

4. Ferric Maltol [usan]

5. St10

6. Ma10qyf1z0

7. Iron(3+);2-methyl-4-oxopyran-3-olate

8. Iron(iii) 2-methyl-4-oxo-4h-pyran-3-olate

9. St10-021

10. Iron Maltol

11. Feraccru (tn)

12. Unii-ma10qyf1z0

13. Ferric Maltol [mi]

14. Ferric Maltol (usan/inn)

15. Ferric Maltol [usan:inn]

16. Ferric Maltol [who-dd]

17. St-10

18. Ferric Maltol [orange Book]

19. Who 9974

20. Db15598

21. Iron(iii)2-methyl-4-oxo-4h-pyran-3-olate

22. D10833

23. E83926

24. Q27283748

25. Iron, Tris(3-hydroxy-2-methyl-4h-pyran-4-onato-o3,o4)-

26. Iron, Tris(3-(hydroxy-.kappa.o)-2-methyl-4h-pyran-4-onato-.kappa.o4)-

27. Tris(3-(hydroxy-.kappa.o)-2-methyl-4h-pyran-4-onato-.kappa.o4)iron(iii)

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 431.2 g/mol
Molecular Formula C18H15FeO9
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count9
Rotatable Bond Count0
Exact Mass431.006543 g/mol
Monoisotopic Mass431.006543 g/mol
Topological Polar Surface Area148 Ų
Heavy Atom Count28
Formal Charge0
Complexity200
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count4
4 Drug and Medication Information
4.1 Drug Indication

Ferric maltol is indicated to treat iron deficiency in adults.


Feraccru is indicated in adults for the treatment of iron deficiency.


Treatment of iron deficiency


5 Pharmacology and Biochemistry
5.1 Pharmacology

Ferric maltol is used to provide supplemental iron to patients with an iron deficiency. It has a wide therapeutic index as patients generally take 30mg twice daily, while concentrations of 20mg/kg may produce toxicity. Patients should be counselled regarding the risk of inflammatory bowel disease flares, iron overload, and accidental ingestion in children.


5.2 MeSH Pharmacological Classification

Hematinics

Agents which improve the quality of the blood, increasing the hemoglobin level and the number of erythrocytes. They are used in the treatment of anemias. (See all compounds classified as Hematinics.)


5.3 FDA Pharmacological Classification
5.3.1 Pharmacological Classes
Parenteral Iron Replacement [EPC]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]; Iron [CS]
5.4 ATC Code

B03AB


B - Blood and blood forming organs

B03 - Antianemic preparations

B03A - Iron preparations

B03AB - Iron trivalent, oral preparations

B03AB10 - Ferric maltol


5.5 Absorption, Distribution and Excretion

Absorption

Ferric maltol dissociates in the gastrointestinal tract, leading to a Tmax of 1.5-3.0 hours for iron concentrations. Mean serum iron increases by 146mol/L in iron deficient patients following a single dose. a 60mg dose is approximately 14% bioavailable. 60 minutes after injection of radiolabelled ferric maltol, 11+2% of the dose is present in the bone marrow, 181% is present in the liver, and 2.61% is in the urine. Maltol has an AUC of 0.022-0.205h\*g/mL and maltol glucuronide has an AUC of 9.83-30.9h\*g/mL.


Route of Elimination

39.8-60% of an oral dose of ferric maltol is excreted in the urine as a glucuronide conjugate. Iron and ferric maltol are not excreted in the urine and unabsorbed ferric maltol is eliminated in the feces.


Volume of Distribution

Data regarding the volume of distribution of ferric maltol is not readily available.


Clearance

Data regarding the clearance of ferric maltol is not readily available.


5.6 Metabolism/Metabolites

_In vitro_, ferric maltol metabolism is predominantly glucuronidation of maltol by UGT1A6 and sulfation.


5.7 Biological Half-Life

Maltol has a half life of 0.7h.


5.8 Mechanism of Action

Ferric maltol dissociates as the iron atom is donated to unknown iron uptake mechanisms, possibly beta 3 integrin or divalent metal transporter 1, in the ileum and duodenum. Once the iron is in circulation, it then associates with transferrin and ferritin.


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24-Mar-2022
01-Jul-2025
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DATA COMPILATION #PharmaFlow

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FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies
In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) approved fewer drugs, there was a significant increase in medical breakthroughs.While the CDER approved 50 new drugs in 2024, as compared to 55 in 2023, the CBER granted 14 biologics approvals in 2024, down from 20 in 2023.The European Medicines Agency (EMA) approved 34 new therapies, up from 32 in 2023, while Health Canada granted 28 approvals, down from 38 in 2023.The year saw long-awaited treatments being approved in areas such as schizophrenia and Alzheimer’s disease in the second half (H2) of 2024. In H1 2024, drugs to treat metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD) had been granted FDA approvals.As the year drew to a close, FDA began approving drugs at a feverish pace, with 29 of the CDER’s 50 approvals coming in H2.Like most years, the landscape of drug approvals was dominated by oncology, with 15 of the 50 drugs (30 percent) approved targeting various forms of cancer. This was followed by dermatology and non-malignant hematology, each accounting for 12 percent of approvals. Notably, small molecules continued to dominate the market, making up for 64 percent of the new drug approvals, while 32 percent were proteins, including monoclonal and bi-specific antibodies. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available)Karuna-BMS’ schizophrenia drug, Lilly’s Alzheimer’s med, Neurocrine’s Crenessity dominate list of pathbreaking approvals in H2Out of the 50 new drugs approved in 2024, CDER identified 24 (48 percent) as first-in-class, showcasing novel mechanisms of action. The most anticipated approval of 2024 was Karuna and Bristol Myers Squibb’s Cobenfy, a groundbreaking treatment for schizophrenia. This fixed-dose combination of xanomeline and trospium chloride represents the first novel mechanism of action in decades for this debilitating psychiatric condition. Analysts forecast peak annual sales of over US$ 3.3 billion for Cobenfy. Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) became the third amyloid-targeting antibody to gain FDA approval. Unlike its predecessors, Kisunla offers a unique limited-duration treatment regimen, allowing patients to discontinue therapy once amyloid levels in the brain drop below a certain threshold. Priced at approximately US$ 32,000 per year, it is positioned as a cost-effective alternative to existing treatments. Analysts estimate peak sales of US$ 2.4 billion for Kisunla.Crenessity (crinecerfont), developed by Neurocrine Biosciences, became the first FDA-approved treatment in decades for classic congenital adrenal hyperplasia (genetic conditions that affect the adrenal glands). Similarly, Vertex’s triple combination therapy of deutivacaftor, tezacaftor & vanzacaftor (Alyftrek) for cystic fibrosis represents a significant advancement in genetic disease treatment. Analysts forecast peak sales exceeding US$ 8.3 billion, underscoring the therapy’s potential to transform patient care.Meanwhile, Bridgebio’s Attruby (acoramidis hydrochloride) emerged as a promising treatment for cardiac amyloidosis, a life-threatening condition. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Roche’s Itovebi, Checkpoint’s Unloxcyt clinch FDA approvals in H2 2024; forecast to achieve blockbuster statusThe dominance of cancer drug approvals reflects the ongoing focus on targeted therapies, immuno-oncology, and precision medicine to improve outcomes for patients with hard-to-treat cancers.Among the year’s notable FDA approvals was Genentech’s Itovebi (inavolisib), another targeted therapy that treats hormone receptor-positive (HR+), HER2-negative breast cancer. Itovebi is a PI3Kα inhibitor designed specifically for patients with PIK3CA mutations, a common driver of resistance to endocrine therapy in breast cancer. It demonstrated a more tolerable safety profile. Roche projects Itovebi’s peak (annual) sales to reach CHF 2 billion (US$ 2.3 billion).Checkpoint Therapeutics’ Unloxcyt (cosibelimab) joined the crowded checkpoint inhibitor market as the eleventh PD-1/PD-L1-targeting monoclonal antibody approved by the FDA. It was granted approval for cutaneous squamous cell carcinoma (cSCC), an aggressive form of skin cancer with high recurrence rates. As compared to other checkpoint inhibitors, like Keytruda (pembrolizumab) and Opdivo (nivolumab), Unloxcyt is likely to offer an advantage in immune activation.FDA also approved Astellas’ Vyloy (zolbetuximab), a first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Analysts forecast peak sales of approximately US$ 850 million for Vyloy.Syndax Pharmaceuticals’ Revuforj (revumenib) was approved by FDA to treat a type of acute leukemia in both adults and children. This approval introduces a novel class of medications known as menin inhibitors. These agents are currently in clinical development for the treatment of genetically defined subsets of acute leukemia. These inhibitors function by preventing the activation of cancer growth-related proteins. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Potential blockbusters Lilly’s Ebglyss, Galderma’s Nemluvio lead advances in dermatologyEli Lilly’s Ebglyss (lebrikizumab) garnered significant attention. Approved by FDA for moderate-to-severe atopic dermatitis, this monoclonal antibody introduces a less burdensome dosing regimen compared to its competitors, with maintenance therapy required only once a month. This feature positions it as a potential contender to Dupixent (dupilumab), a market leader in atopic dermatitis. Ebglyss sales are forecast to reach US$ 1.9 billion by 2030.Galderma’s Nemluvio (nemolizumab) secured FDA approval for two indications in 2024 — prurigo nodularis (a chronic disorder of the skin) and moderate-to-severe atopic dermatitis in patients aged 12 years and older. As the first humanized IgG2 monoclonal antibody targeting the IL-31 receptor, Nemluvio directly inhibits the key driver of itch and inflammation in both these conditions. With its unique mechanism and broad dermatology potential, analysts forecast peak sales of approximately US$ 1.66 billion. Ebglyss and Nemluvio underscore the growing importance of biologics in dermatological care.Botanix Pharmaceuticals also made strides in dermatology by clinching an FDA approval for Sofdra (sofpironium) in June. The drug has been okayed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.Ascendis Pharma’s Yorvipath (palopegteriparatide), a therapy approved by FDA to treat hypoparathyroidism, is forecast to achieve blockbuster sales of US$ 1.8 billion by 2030, highlighting its potential to transform endocrine care. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Our viewOverall, 2024 was defined by its breakthrough drug approvals. The year also saw significant reduction in complete response letters (CRLs) — they dropped from 43 in 2023 to just 29 in 2024. This suggests improved industry preparedness and alignment with regulatory expectations.The new year began with the approval of Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, marking a significant advancement in oncology. Several other promising new drugs are coming up for FDA approval this year, such as J&J’s nipocalimab, Vertex Pharmaceuticals’ suzetrigine, Elevar Therapeutics’ rivoceranib/camrelizumab, Sanofi’s fitusiran and GSK’s gepotidacin. Hopefully, the momentum of breakthrough approvals will continue through 2025, political headwinds in the US notwithstanding. 

Impressions: 11123

https://www.pharmacompass.com/radio-compass-blog/fda-okays-50-new-drugs-in-2024-bms-cobenfy-lilly-s-kisunla-lead-pack-of-breakthrough-therapies

#PharmaFlow by PHARMACOMPASS
30 Jan 2025

NEWS #PharmaBuzz

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Looking for 33725-54-1 / Ferric Maltol API manufacturers, exporters & distributors?

Ferric Maltol manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Ferric Maltol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ferric Maltol manufacturer or Ferric Maltol supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ferric Maltol manufacturer or Ferric Maltol supplier.

PharmaCompass also assists you with knowing the Ferric Maltol API Price utilized in the formulation of products. Ferric Maltol API Price is not always fixed or binding as the Ferric Maltol Price is obtained through a variety of data sources. The Ferric Maltol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Ferric Maltol

Synonyms

33725-54-1, Iron (iii) maltol, Ferric maltol [inn], Ferric maltol [usan], St10, Ma10qyf1z0

Cas Number

33725-54-1

Unique Ingredient Identifier (UNII)

MA10QYF1Z0

About Ferric Maltol

Ferric maltol is an iron(III) atom complexed with 3 maltol molecules to increase the bioavailability compared to iron(II), without depositing it in the duodenum as insoluble ferric hydroxide and phosphate. Ferric maltol has been described in literature since at least the late 1980s as a potential treatment for iron deficiency. Ferric maltol was granted FDA Approval on 25 July 2019.

Ferric Maltol Manufacturers

A Ferric Maltol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ferric Maltol, including repackagers and relabelers. The FDA regulates Ferric Maltol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ferric Maltol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Ferric Maltol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Ferric Maltol Suppliers

A Ferric Maltol supplier is an individual or a company that provides Ferric Maltol active pharmaceutical ingredient (API) or Ferric Maltol finished formulations upon request. The Ferric Maltol suppliers may include Ferric Maltol API manufacturers, exporters, distributors and traders.

click here to find a list of Ferric Maltol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Ferric Maltol WC

A Ferric Maltol written confirmation (Ferric Maltol WC) is an official document issued by a regulatory agency to a Ferric Maltol manufacturer, verifying that the manufacturing facility of a Ferric Maltol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ferric Maltol APIs or Ferric Maltol finished pharmaceutical products to another nation, regulatory agencies frequently require a Ferric Maltol WC (written confirmation) as part of the regulatory process.

click here to find a list of Ferric Maltol suppliers with Written Confirmation (WC) on PharmaCompass.

Ferric Maltol NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Ferric Maltol as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ferric Maltol API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Ferric Maltol as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Ferric Maltol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ferric Maltol NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Ferric Maltol suppliers with NDC on PharmaCompass.

Ferric Maltol GMP

Ferric Maltol Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Ferric Maltol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Ferric Maltol GMP manufacturer or Ferric Maltol GMP API supplier for your needs.

Ferric Maltol CoA

A Ferric Maltol CoA (Certificate of Analysis) is a formal document that attests to Ferric Maltol's compliance with Ferric Maltol specifications and serves as a tool for batch-level quality control.

Ferric Maltol CoA mostly includes findings from lab analyses of a specific batch. For each Ferric Maltol CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Ferric Maltol may be tested according to a variety of international standards, such as European Pharmacopoeia (Ferric Maltol EP), Ferric Maltol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ferric Maltol USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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