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Also known as: 1306760-87-1, Rpc1063, Rpc-1063, Ozanimod (rpc1063), (s)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1h-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile, Z80293urpv
Molecular Formula
C23H24N4O3
Molecular Weight
404.5  g/mol
InChI Key
XRVDGNKRPOAQTN-FQEVSTJZSA-N
FDA UNII
Z80293URPV

Ozanimod
Ozanimod is an orally bioavailable sphingosine-1-phosphate (S1P) receptors 1 (S1PR1, S1P1) and 5 (S1PR5, S1P5) modulator, with potential anti-inflammatory and immunomodulating activities. Upon oral administration, ozanimod selectively targets and binds to S1PR1 on lymphocytes and induces S1PR1 internalization and degradation. This results in the sequestration of lymphocytes in lymph nodes. By preventing egress of lymphocytes, ozanimod reduces both the amount of circulating peripheral lymphocytes and the infiltration of lymphocytes into target tissues. This prevents a lymphocyte-mediated immune response and may reduce inflammation. S1PR1, a G-protein coupled receptor, plays a key role in lymphocyte migration from lymphoid tissues. Modulation of S1PR5 by ozanimod may be neuroprotective.
1 2D Structure

Ozanimod

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
5-[3-[(1S)-1-(2-hydroxyethylamino)-2,3-dihydro-1H-inden-4-yl]-1,2,4-oxadiazol-5-yl]-2-propan-2-yloxybenzonitrile
2.1.2 InChI
InChI=1S/C23H24N4O3/c1-14(2)29-21-9-6-15(12-16(21)13-24)23-26-22(27-30-23)19-5-3-4-18-17(19)7-8-20(18)25-10-11-28/h3-6,9,12,14,20,25,28H,7-8,10-11H2,1-2H3/t20-/m0/s1
2.1.3 InChI Key
XRVDGNKRPOAQTN-FQEVSTJZSA-N
2.1.4 Canonical SMILES
CC(C)OC1=C(C=C(C=C1)C2=NC(=NO2)C3=C4CCC(C4=CC=C3)NCCO)C#N
2.1.5 Isomeric SMILES
CC(C)OC1=C(C=C(C=C1)C2=NC(=NO2)C3=C4CC[C@@H](C4=CC=C3)NCCO)C#N
2.2 Other Identifiers
2.2.1 UNII
Z80293URPV
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Rpc1063

2.3.2 Depositor-Supplied Synonyms

1. 1306760-87-1

2. Rpc1063

3. Rpc-1063

4. Ozanimod (rpc1063)

5. (s)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1h-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile

6. Z80293urpv

7. Zeposia

8. Unii-z80293urpv

9. Benzonitrile, 5-(3-((1s)-2,3-dihydro-1-((2-hydroxyethyl)amino)-1h-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-(1-methylethoxy)-

10. Ozanimod [inn]

11. 5-[3-[(1~{s})-1-(2-hydroxyethylamino)-2,3-dihydro-1~{h}-inden-4-yl]-1,2,4-oxadiazol-5-yl]-2-propan-2-yloxy-benzenecarbonitrile

12. Benzonitrile, 5-[3-[(1s)-2,3-dihydro-1-[(2-hydroxyethyl)amino]-1h-inden-4-yl]-1,2,4-oxadiazol-5-yl]-2-(1-methylethoxy)-

13. Ozanimod [usan:inn]

14. 5-[3-[(1s)-1-(2-hydroxyethylamino)-2,3-dihydro-1h-inden-4-yl]-1,2,4-oxadiazol-5-yl]-2-propan-2-yloxybenzonitrile

15. Rpc 1063

16. Ozanimod [usan]

17. Ozanimod; Rpc1063

18. Ozanimod (usan/inn)

19. Ozanimod [mi]

20. Ozanimod [who-dd]

21. Gtpl8709

22. Schembl2195490

23. Chembl3707247

24. Amy3373

25. Dtxsid501026488

26. Bcp16513

27. Ex-a1316

28. Rpc1063:rpc-1063

29. Bdbm50507186

30. Mfcd28386168

31. S7952

32. Akos026674086

33. Zinc116109867

34. Ccg-268695

35. Cs-5070

36. Db12612

37. Ac-29883

38. As-75063

39. Hy-12288

40. J3.612.016i

41. D10968

42. P14657

43. Q21098986

44. 5-{3-[(1s)-1-[(2-hydroxyethyl)amino]-2,3-dihydro-1h-inden-4-yl]-1,2,4-oxadiazol-5-yl}-2-(propan-2-yloxy)benzonitrile

45. Jeu

2.4 Create Date
2011-06-13
3 Chemical and Physical Properties
Molecular Weight 404.5 g/mol
Molecular Formula C23H24N4O3
XLogP33.1
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count7
Rotatable Bond Count7
Exact Mass404.18484064 g/mol
Monoisotopic Mass404.18484064 g/mol
Topological Polar Surface Area104 Ų
Heavy Atom Count30
Formal Charge0
Complexity609
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Ozanimod is indicated for adults in the treatment of relapsing forms of MS, which may include relapsing-remitting disease, clinically isolated syndrome, and active secondary progressive MS.


FDA Label


Multiple sclerosis

- Zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.

Ulcerative colitis

- Zeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Ozanimod reduces circulating lymphocytes that cause the neuroinflammation associated with MS, reducing debilitating symptoms and, possibly, disease progression. During clinical trials, ozanimod reduced MS-associated brain volume loss in several regions. Ozanimod causes the sequestration of peripheral lymphocytes, reducing circulating lymphocytes in the gastrointestinal tract.


5.2 MeSH Pharmacological Classification

Sphingosine 1 Phosphate Receptor Modulators

Agents that affect the function of G-protein coupled SPHINGOSINE 1-PHOSPHATE RECEPTORS. Their binding to the receptors blocks lymphocyte migration and are often used as IMMUNOSUPPRESSANTS. (See all compounds classified as Sphingosine 1 Phosphate Receptor Modulators.)


5.3 ATC Code

L04AA38


L - Antineoplastic and immunomodulating agents

L04 - Immunosuppressants

L04A - Immunosuppressants

L04AA - Selective immunosuppressants

L04AA38 - Ozanimod


5.4 Absorption, Distribution and Excretion

Absorption

Ozanimod is absorbed in the gastrointestinal tract after oral administration. The Cmax of ozanimod is 0.244 ng/mL and is achieved at 6 to 8 hours after administration, reaching steady-state at about 102 hours after administration. The AUC is 4.46 ng*h/mL. Its delayed absorption reduces effects that may occur after the first dose, such as heart rate changes. The peak plasma concentration of ozanimod is low due to a high volume of distribution.


Route of Elimination

The kidneys are not a major source of elimination for ozanimod. After a 0.92 mg dose of radiolabeled ozanimod was administered, about 26% of the labeled drug was accounted for in the urine and 37 % in the feces, mainly in the form of inactive metabolites.


Volume of Distribution

The average volume of distribution of ozanimod is 5590L. Another reference mentions a volume of distribution ranging from 73-101 L/kg. This drug crosses the blood-brain barrier.


Clearance

The mean apparent oral clearance of ozanimod, according to prescribing information, is 192 L/h. Another reference indicates an oral clearance of 233 L/h.


5.5 Metabolism/Metabolites

Ozanimod has two major active metabolites CC112273 and CC1084037 and minor active metabolites such as RP101988, RP101075, and RP101509, which target the S1P1 and S1P5 receptors. The enzymes involved in the metabolism of ozanimod include ALDH/ADH, NAT-2, Monoamine Oxidase B, and AKR 1C1/1C2. After metabolism, ozanimod (6%), CC112273 (73%), and CC1084037 (15%) are accounted for in the circulation.


5.6 Biological Half-Life

The half-life of ozanimod ranges from 17-21 hours.


5.7 Mechanism of Action

Sphingosine1phosphate (S1P) is an important phospholipid that binds to various Gproteincoupled receptor subtypes, which can be identified as S1P15R. S1P and the receptors it binds to perform regular functions in the immune, cardiovascular, pulmonary, and nervous system. S1P can be expressed ubiquitously, playing an important role in regulating inflammation. S1P1R, S1P2R, and S1P3R receptors can be found in the cardiovascular, immune, and central nervous systems. S1P4R is found on lymphocytic and hematopoietic cells, while S1P5R expression is found only on the spleen (on natural killer cells) or in the central nervous system. Ozanimod is a selective modulator of S1P receptors and binds to S1P1R and S1P5R subtypes. The mechanism of action of ozanimod is not fully understood, but this drug likely reduces the migration of lymphocytes that usually aggravate the inflammation associated with MS.


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Polpharma

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Egis Pharmaceuticals PLC

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Maithri Drugs

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Maithri Drugs

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Synthon Pharmaceuticals

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Wacker Chemie AG

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Polpharma

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Polpharma API, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API development to scale-up, at our FDA-approved plant in Central Europe. Our expert team provides high-quality, tailor-made services for small molecule API clinical candidates, with strong regulatory support and world-class facilities. Trusted by global partners, we specialize in complex chemical processes and deliver exceptional customer experiences. Polpharma API – Your reliable European CDMO partner.
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Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could 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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Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its products under Egis’ brand names in 18 countries. In total, the company’s APIs & finished products reach 100 countries. Egis’ focus lies on treating diseases of cardiovascular & central nervous systems; however, it also provides modern treatment solutions in the fields of diabetology, dermatology & wound care. Our research and development activities focus on high-quality, value-added branded generic products. From 2023, Egis offers its CDMO & CMO services as well.
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Ozanimod Hydrochloride

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Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For the past three years, the company focused on extracting alkaloid opiates, controlled substances, and narcotics. The APIs are widely used by major pharmaceutical companies nationwide and exported to the Middle East. All production adheres to local GMP standards in an SOP-driven environment with modern systems and utilities, ensuring the highest quality and safety.
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CHEMO

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About the Company : More than 35 years of dedication to quality, service and pursuit of excellence, CHEMO was founded by Hugo Sigman, M.D., and Silvia Gold, Biochemist, in Spain (Barcelona), in 1977, ...

More than 35 years of dedication to quality, service and pursuit of excellence, CHEMO was founded by Hugo Sigman, M.D., and Silvia Gold, Biochemist, in Spain (Barcelona), in 1977, and starts business activities trading with pharmaceutical raw materials. In the 80's, the company expanded its operations into the Industrial Business, developing and manufacturing active pharmaceutical ingredients (APIs) in Italy (Industriale Chimica) and in Spain (Quimica Sintetica). In the 90's, CHEMO starts developing and manufacturing high quality and technology finished dosage forms (FDFs).
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About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...

Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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About the Company : Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its ex...

Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its excellent research & development and aggressive growth strategies. Our 32 US DMFs and 9 CEPs in a short span attest to our R&D excellence. Maithri's manufacturing facility is located in Hyderabad. This facility is audited and approved by the US FDA. In addition, our facility is certified according to the standards of DCGI, WHO GMP, and ISO 9001:2015 We have a portfolio of 65 products and are continually expanding.
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Ozanimod HCl

About the Company : Parsian Pharmaceutical is dedicated to improving health outcomes by offering high-quality, effective pharmaceutical products. With a strong commitment to research, innovation, and ...

Parsian Pharmaceutical is dedicated to improving health outcomes by offering high-quality, effective pharmaceutical products. With a strong commitment to research, innovation, and quality, Parsian Pharmaceutical develops and manufactures a broad range of medications designed to meet international standards and address diverse therapeutic needs. Serving both local and global markets, Parsian Pharmaceutical strives to be a trusted healthcare partner, providing reliable, accessible solutions that enhance patient care and contribute to a healthier society.
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04-Feb-2025
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Brand Name : Zeposia

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Brand Name : Zeposia

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Ozanimod

Dosage Form : Caps

Dosage Strength : 0.92mg

Price Per Pack (Euro) : 1175.82

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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Brand Name : Zeposia starter pack

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Brand Name : Zeposia starter pack

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Ozanimod

Dosage Form : Caps

Dosage Strength : 0.23mg and 0.46mg

Price Per Pack (Euro) : 293.96

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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API | Excipient name

Ozanimod

Synonyms

1306760-87-1, Rpc1063, Rpc-1063, Ozanimod (rpc1063), (s)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1h-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile, Z80293urpv

Cas Number

1306760-87-1

Unique Ingredient Identifier (UNII)

Z80293URPV

About Ozanimod

Ozanimod is an orally bioavailable sphingosine-1-phosphate (S1P) receptors 1 (S1PR1, S1P1) and 5 (S1PR5, S1P5) modulator, with potential anti-inflammatory and immunomodulating activities. Upon oral administration, ozanimod selectively targets and binds to S1PR1 on lymphocytes and induces S1PR1 internalization and degradation. This results in the sequestration of lymphocytes in lymph nodes. By preventing egress of lymphocytes, ozanimod reduces both the amount of circulating peripheral lymphocytes and the infiltration of lymphocytes into target tissues. This prevents a lymphocyte-mediated immune response and may reduce inflammation. S1PR1, a G-protein coupled receptor, plays a key role in lymphocyte migration from lymphoid tissues. Modulation of S1PR5 by ozanimod may be neuroprotective.

Ozanimod Hydrochloride Manufacturers

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

Ozanimod Hydrochloride Suppliers

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

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

Ozanimod Hydrochloride USDMF

A Ozanimod Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Ozanimod Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Ozanimod Hydrochloride DMFs exist exist since differing nations have different regulations, such as Ozanimod Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Ozanimod Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Ozanimod Hydrochloride USDMF includes data on Ozanimod Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ozanimod Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Ozanimod Hydrochloride suppliers with USDMF on PharmaCompass.

Ozanimod Hydrochloride 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 Ozanimod Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ozanimod Hydrochloride 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 Ozanimod Hydrochloride 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 Ozanimod Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ozanimod Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Ozanimod Hydrochloride suppliers with NDC on PharmaCompass.

Ozanimod Hydrochloride GMP

Ozanimod Hydrochloride 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 Ozanimod Hydrochloride 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 Ozanimod Hydrochloride GMP manufacturer or Ozanimod Hydrochloride GMP API supplier for your needs.

Ozanimod Hydrochloride CoA

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

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

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