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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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NDC API

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VMF

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USP

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Chemistry

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Also known as: Rusfertide [usan], Xm71myx0iq, Ptg-300fb, Ptg-300, 1628323-80-7, Isovaleryl-asp-thr-his-phe-pro-cyclo(cys-ile-lys(palm-gamma-glu)- phe-glu-pro-arg-ser-lys-gly-cys)-lys-nh2
Molecular Formula
C114H181N27O28S2
Molecular Weight
2442.0  g/mol
InChI Key
JRVOBXXOZFTSRF-GVIPULMVSA-N
FDA UNII
XM71MYX0IQ

Rusfertide
Rusfertide is an injectable peptide mimetic of hepcidin (hepcidin antimicrobial peptide; HAMP; putative liver tumor regressor; PLTR; liver-expressed antimicrobial peptide 1; LEAP-1) with potential use in the treatment of iron deficiency anemia and iron overload secondary to hematologic disorders. Upon administration, rusfertide mimics endogenous hepcidin, a protein primarily produced in hepatocytes, and increases hepcidin levels. As hepcidin plays a key role in the homeostasis of systemic iron, rusfertide may serve to normalize iron levels. Low levels of endogenous hepcidin are associated with iron overload secondary to excessive absorption of iron as seen in beta thalassemia and paradoxically with iron deficiency anemia.
1 2D Structure

Rusfertide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-5-[4-[(3S,6S,9S,12S,15R,20R,26S,29S,32S,35S)-26-(4-aminobutyl)-6-benzyl-12-[(2S)-butan-2-yl]-32-(3-carbamimidamidopropyl)-3-(2-carboxyethyl)-15-[[(2S)-1-[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-3-carboxy-2-(3-methylbutanoylamino)propanoyl]amino]-3-hydroxybutanoyl]amino]-3-(1H-imidazol-4-yl)propanoyl]amino]-3-phenylpropanoyl]pyrrolidine-2-carbonyl]amino]-20-[[(2S)-1,6-diamino-1-oxohexan-2-yl]carbamoyl]-29-(hydroxymethyl)-2,5,8,11,14,22,25,28,31,34-decaoxo-17,18-dithia-1,4,7,10,13,21,24,27,30,33-decazabicyclo[33.3.0]octatriacontan-9-yl]butylamino]-2-(hexadecanoylamino)-5-oxopentanoic acid
2.1.2 InChI
InChI=1S/C114H181N27O28S2/c1-7-9-10-11-12-13-14-15-16-17-18-19-26-46-90(145)125-79(113(168)169)47-49-89(144)121-53-32-29-42-76-99(154)133-80(58-71-36-22-20-23-37-71)101(156)132-78(48-50-93(148)149)111(166)140-55-34-44-87(140)107(162)130-77(43-33-54-122-114(118)119)100(155)136-84(64-142)104(159)129-75(41-28-31-52-116)98(153)123-63-92(147)127-85(105(160)128-74(97(117)152)40-27-30-51-115)65-170-171-66-86(106(161)138-95(69(5)8-2)109(164)131-76)137-108(163)88-45-35-56-141(88)112(167)83(59-72-38-24-21-25-39-72)135-102(157)81(60-73-62-120-67-124-73)134-110(165)96(70(6)143)139-103(158)82(61-94(150)151)126-91(146)57-68(3)4/h20-25,36-39,62,67-70,74-88,95-96,142-143H,7-19,26-35,40-61,63-66,115-116H2,1-6H3,(H2,117,152)(H,120,124)(H,121,144)(H,123,153)(H,125,145)(H,126,146)(H,127,147)(H,128,160)(H,129,159)(H,130,162)(H,131,164)(H,132,156)(H,133,154)(H,134,165)(H,135,157)(H,136,155)(H,137,163)(H,138,161)(H,139,158)(H,148,149)(H,150,151)(H,168,169)(H4,118,119,122)/t69-,70+,74-,75-,76-,77-,78-,79-,80-,81-,82-,83-,84-,85-,86-,87-,88-,95-,96-/m0/s1
2.1.3 InChI Key
JRVOBXXOZFTSRF-GVIPULMVSA-N
2.1.4 Canonical SMILES
CCCCCCCCCCCCCCCC(=O)NC(CCC(=O)NCCCCC1C(=O)NC(C(=O)NC(C(=O)N2CCCC2C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NCC(=O)NC(CSSCC(C(=O)NC(C(=O)N1)C(C)CC)NC(=O)C3CCCN3C(=O)C(CC4=CC=CC=C4)NC(=O)C(CC5=CNC=N5)NC(=O)C(C(C)O)NC(=O)C(CC(=O)O)NC(=O)CC(C)C)C(=O)NC(CCCCN)C(=O)N)CCCCN)CO)CCCNC(=N)N)CCC(=O)O)CC6=CC=CC=C6)C(=O)O
2.1.5 Isomeric SMILES
CCCCCCCCCCCCCCCC(=O)N[C@@H](CCC(=O)NCCCC[C@H]1C(=O)N[C@H](C(=O)N[C@H](C(=O)N2CCC[C@H]2C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)NCC(=O)N[C@@H](CSSC[C@@H](C(=O)N[C@H](C(=O)N1)[C@@H](C)CC)NC(=O)[C@@H]3CCCN3C(=O)[C@H](CC4=CC=CC=C4)NC(=O)[C@H](CC5=CNC=N5)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CC(=O)O)NC(=O)CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N)CCCCN)CO)CCCNC(=N)N)CCC(=O)O)CC6=CC=CC=C6)C(=O)O
2.2 Other Identifiers
2.2.1 UNII
XM71MYX0IQ
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Rusfertide [usan]

2. Xm71myx0iq

3. Ptg-300fb

4. Ptg-300

5. 1628323-80-7

6. Isovaleryl-asp-thr-his-phe-pro-cyclo(cys-ile-lys(palm-gamma-glu)- Phe-glu-pro-arg-ser-lys-gly-cys)-lys-nh2

7. Rusfertide [inn]

8. Unii-xm71myx0iq

9. Who 11456

10. L-lysinamide, N-(3-methyl-1-oxobutyl)-l-.alpha.-aspartyl-l-threonyl-l-histidyl-l-phenylalanyl-l-prolyl-l-cysteinyl-l-isoleucyl-n6-(n-(1-oxohexadecyl)-l-.gamma.-glutamyl)-l-lysyl-l-phenylalanyl-l-.alpha.-glutamyl-l-prolyl-l-arginyl-l-seryl-l-lysylglycyl-l-cysteinyl-

11. N-(3-methyl-1-oxobutyl)-l-.alpha.-aspartyl-l-threonyl-l-histidyl-l-phenylalanyl-l-prolyl-l-cysteinyl-l-isoleucyl-n6-(n-(1-oxohexadecyl)-l-.gamma.-glutamyl)-l-lysyl-l-phenylalanyl-l-.alpha.-glutamyl-l-prolyl-l-arginyl-l-seryl-l-lysylglycyl-l-cysteinyl-l-lysinamide

2.4 Create Date
2021-04-15
3 Chemical and Physical Properties
Molecular Weight 2442.0 g/mol
Molecular Formula C114H181N27O28S2
XLogP3-1.5
Hydrogen Bond Donor Count29
Hydrogen Bond Acceptor Count34
Rotatable Bond Count67
Exact Mass2441.3044354 g/mol
Monoisotopic Mass2440.3010806 g/mol
Topological Polar Surface Area924 Ų
Heavy Atom Count171
Formal Charge0
Complexity5090
Isotope Atom Count0
Defined Atom Stereocenter Count19
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

Listed Suppliers

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Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Rusfertide

About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...

Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios with over 350 products, alongside tailored CDMO services. Leveraging deep expertise and diverse technologies, we deliver flexible, high-quality solutions to meet our partners’ needs. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
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Drugs in Development

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Details:

In a divestment deal, Rusfertide, an unconjugated peptide targeting hepcidin, is being sold to focus on polycythemia vera treatment.


Lead Product(s): Rusfertide,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Peptide, Unconjugated

Sponsor: Takeda Pharmaceutical

Deal Size: $1,750.0 million Upfront Cash: $300.0 million

Deal Type: Divestment April 28, 2026

blank

01

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : In a divestment deal, Rusfertide, an unconjugated peptide targeting hepcidin, is being sold to focus on polycythemia vera treatment.

Product Name : Undisclosed

Product Type : Peptide, Unconjugated

Upfront Cash : $300.0 million

April 28, 2026

blank

Details:

PTG-300 (rusfertide) is a hepcidin inhibitor, which is being evaluated in the Phase III clinical trial studies with patients for the treatment of Polycythemia Vera.


Lead Product(s): Rusfertide,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Peptide, Unconjugated

Sponsor: Takeda Pharmaceutical

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 03, 2025

blank

02

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : PTG-300 (rusfertide) is a hepcidin inhibitor, which is being evaluated in the Phase III clinical trial studies with patients for the treatment of Polycythemia Vera.

Product Name : Undisclosed

Product Type : Peptide, Unconjugated

Upfront Cash : Inapplicable

March 03, 2025

blank

Details:

PTG-300 (rusfertide) is a hepcidin inhibitor, which is being evaluated in the Phase III clinical trial studies with patients for the treatment of Polycythemia Vera.


Lead Product(s): Rusfertide,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Peptide, Unconjugated

Sponsor: Takeda Pharmaceutical

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 26, 2024

blank

03

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : PTG-300 (rusfertide) is a hepcidin inhibitor, which is being evaluated in the Phase III clinical trial studies with patients for the treatment of Polycythemia Vera.

Product Name : Undisclosed

Product Type : Peptide, Unconjugated

Upfront Cash : Inapplicable

March 26, 2024

blank

Details:

The collaboration supports PTG-300 (rusfertide) development for Polycythemia Vera, with the protagonist responsible for research and completing the Phase 3 trial and U.S. regulatory approval.


Lead Product(s): Rusfertide,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Peptide, Unconjugated

Sponsor: Takeda Pharmaceutical

Deal Size: Undisclosed Upfront Cash: $300.0 million

Deal Type: Collaboration March 18, 2024

blank

04

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : The collaboration supports PTG-300 (rusfertide) development for Polycythemia Vera, with the protagonist responsible for research and completing the Phase 3 trial and U.S. regulatory approval.

Product Name : Undisclosed

Product Type : Peptide, Unconjugated

Upfront Cash : $300.0 million

March 18, 2024

blank

Details:

The collaboration supports the development of PTG-300 (rusfertide) for Polycythemia Vera. The protagonist is responsible for completing the Phase 3 trial and U.S. regulatory approval.


Lead Product(s): Rusfertide,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Peptide, Unconjugated

Sponsor: Takeda Pharmaceutical

Deal Size: Undisclosed Upfront Cash: $300.0 million

Deal Type: Collaboration January 31, 2024

blank

05

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : The collaboration supports the development of PTG-300 (rusfertide) for Polycythemia Vera. The protagonist is responsible for completing the Phase 3 trial and U.S. regulatory approval.

Product Name : Undisclosed

Product Type : Peptide, Unconjugated

Upfront Cash : $300.0 million

January 31, 2024

blank

Details:

Rusfertide is a Peptide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Polycythemia Vera.


Lead Product(s): Rusfertide,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Peptide, Unconjugated

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 13, 2023

blank

06

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : Rusfertide is a Peptide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Polycythemia Vera.

Product Name : Undisclosed

Product Type : Peptide, Unconjugated

Upfront Cash : Inapplicable

September 13, 2023

blank

Details:

The net proceeds intends to fund the continued clinical development and pre-commercialization activities associated with PTG-300 (rusfertide), an injectable hepcidin mimetic in development for the treatment of polycythemia vera and other blood disorders.


Lead Product(s): Rusfertide,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Peptide, Unconjugated

Sponsor: J.P. Morgan

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering April 04, 2023

blank

07

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Lead Product(s) : Rusfertide,Inapplicable

Therapeutic Area : Oncology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : J.P. Morgan

Deal Size : $100.0 million

Deal Type : Public Offering

Details : The net proceeds intends to fund the continued clinical development and pre-commercialization activities associated with PTG-300 (rusfertide), an injectable hepcidin mimetic in development for the treatment of polycythemia vera and other blood disorders.

Product Name : Undisclosed

Product Type : Peptide, Unconjugated

Upfront Cash : Undisclosed

April 04, 2023

blank

Details:

PTG-300 (rusfertide) is a hepcidin-mimetic that helps reduce iron availability to help achieve hematocrit control and decrease erythropoiesis in patients with polycythemia vera (PV) without the need for periodic therapeutic phlebotomy.


Lead Product(s): Rusfertide,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Peptide, Unconjugated

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 15, 2023

blank

08

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : PTG-300 (rusfertide) is a hepcidin-mimetic that helps reduce iron availability to help achieve hematocrit control and decrease erythropoiesis in patients with polycythemia vera (PV) without the need for periodic therapeutic phlebotomy.

Product Name : Undisclosed

Product Type : Peptide, Unconjugated

Upfront Cash : Inapplicable

March 15, 2023

blank

Details:

Rusfertide is a Peptide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Polycythemia Vera.


Lead Product(s): Rusfertide,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Peptide, Unconjugated

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 27, 2022

blank

09

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : Rusfertide is a Peptide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Polycythemia Vera.

Product Name : Undisclosed

Product Type : Peptide, Unconjugated

Upfront Cash : Inapplicable

January 27, 2022

blank

Details:

The rasH2 signal also prompted a re-examination of the four cases of cancer observed across all rusfertide clinical trials involving over 160 patients, and a comprehensive review of the safety database, including cases of suspected unexpected serious adverse reactions (SUSAR).


Lead Product(s): Rusfertide,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Peptide, Unconjugated

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 11, 2021

blank

10

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : The rasH2 signal also prompted a re-examination of the four cases of cancer observed across all rusfertide clinical trials involving over 160 patients, and a comprehensive review of the safety database, including cases of suspected unexpected serious adv...

Product Name : Undisclosed

Product Type : Peptide, Unconjugated

Upfront Cash : Inapplicable

October 11, 2021

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ABOUT THIS PAGE

Looking for 1628323-80-7 / Rusfertide API manufacturers, exporters & distributors?

Rusfertide manufacturers, exporters & distributors 1

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

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

API | Excipient name

Rusfertide

Synonyms

Rusfertide [usan], Xm71myx0iq, Ptg-300fb, Ptg-300, 1628323-80-7, Isovaleryl-asp-thr-his-phe-pro-cyclo(cys-ile-lys(palm-gamma-glu)- phe-glu-pro-arg-ser-lys-gly-cys)-lys-nh2

Cas Number

1628323-80-7

Unique Ingredient Identifier (UNII)

XM71MYX0IQ

About Rusfertide

Rusfertide is an injectable peptide mimetic of hepcidin (hepcidin antimicrobial peptide; HAMP; putative liver tumor regressor; PLTR; liver-expressed antimicrobial peptide 1; LEAP-1) with potential use in the treatment of iron deficiency anemia and iron overload secondary to hematologic disorders. Upon administration, rusfertide mimics endogenous hepcidin, a protein primarily produced in hepatocytes, and increases hepcidin levels. As hepcidin plays a key role in the homeostasis of systemic iron, rusfertide may serve to normalize iron levels. Low levels of endogenous hepcidin are associated with iron overload secondary to excessive absorption of iron as seen in beta thalassemia and paradoxically with iron deficiency anemia.

Rusfertide Manufacturers

A Rusfertide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rusfertide, including repackagers and relabelers. The FDA regulates Rusfertide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rusfertide 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 Rusfertide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.

Rusfertide Suppliers

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

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

Rusfertide GMP

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

Rusfertide CoA

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

Rusfertide CoA mostly includes findings from lab analyses of a specific batch. For each Rusfertide 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.

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