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Chemistry

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Also known as: Sndx-5613, 2169919-21-3, Lz0m43nnf2, Sndx5613, Sndx-5613 free base, N-ethyl-2-[4-[7-[[4-(ethylsulfonylamino)cyclohexyl]methyl]-2,7-diazaspiro[3.5]nonan-2-yl]pyrimidin-5-yl]oxy-5-fluoro-n-propan-2-ylbenzamide
Molecular Formula
C32H47FN6O4S
Molecular Weight
630.8  g/mol
InChI Key
FRVSRBKUQZKTOW-UHFFFAOYSA-N
FDA UNII
LZ0M43NNF2

Revumenib
Revumenib is an orally bioavailable protein-protein interaction (PPI) inhibitor of the menin-mixed lineage leukemia (MLL; myeloid/lymphoid leukemia; KMT2A) proteins, with potential antineoplastic activity. Upon oral administration, revumenib targets and binds to the nuclear protein menin, thereby preventing the interaction between the two proteins menin and MLL and the formation of the menin-MLL complex. This reduces the expression of downstream target genes and results in an inhibition of the proliferation of MLL-rearranged leukemic cells. The menin-MLL complex plays a key role in the survival, growth, transformation and proliferation of certain kinds of leukemia cells.
1 2D Structure

Revumenib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-ethyl-2-[4-[7-[[4-(ethylsulfonylamino)cyclohexyl]methyl]-2,7-diazaspiro[3.5]nonan-2-yl]pyrimidin-5-yl]oxy-5-fluoro-N-propan-2-ylbenzamide
2.1.2 InChI
InChI=1S/C32H47FN6O4S/c1-5-39(23(3)4)31(40)27-17-25(33)9-12-28(27)43-29-18-34-22-35-30(29)38-20-32(21-38)13-15-37(16-14-32)19-24-7-10-26(11-8-24)36-44(41,42)6-2/h9,12,17-18,22-24,26,36H,5-8,10-11,13-16,19-21H2,1-4H3
2.1.3 InChI Key
FRVSRBKUQZKTOW-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCN(C(C)C)C(=O)C1=C(C=CC(=C1)F)OC2=CN=CN=C2N3CC4(C3)CCN(CC4)CC5CCC(CC5)NS(=O)(=O)CC
2.2 Other Identifiers
2.2.1 UNII
LZ0M43NNF2
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Sndx-5613

2. 2169919-21-3

3. Lz0m43nnf2

4. Sndx5613

5. Sndx-5613 Free Base

6. N-ethyl-2-[4-[7-[[4-(ethylsulfonylamino)cyclohexyl]methyl]-2,7-diazaspiro[3.5]nonan-2-yl]pyrimidin-5-yl]oxy-5-fluoro-n-propan-2-ylbenzamide

7. Sndx50613

8. Benzamide, N-ethyl-2-((4-(7-((trans-4-((ethylsulfonyl)amino)cyclohexyl)methyl)-2,7-diazaspiro(3.5)non-2-yl)-5-pyrimidinyl)oxy)-5-fluoro-n-(1-methylethyl)-

9. Sndx-50613

10. Revumenib [inn]

11. Unii-lz0m43nnf2

12. Sndx5613 Free Base

13. Sndx50613 Free Base

14. Chembl4650827

15. Schembl19693219

16. Schembl19693428

17. Gtpl11882

18. Sndx-50613 Free Base

19. Ex-a4343

20. Nsc825775

21. S8996

22. Nsc-825775

23. Ac-36885

24. Hy-136175

25. Cs-0120274

26. N-ethyl-2-((4-(7-(((1r,4r)-4-(ethylsulfonamido)cyclohexyl)methyl)-2,7-diazaspiro[3.5]nonan-2-yl)pyrimidin-5-yl)oxy)-5-fluoro-n-isopropylbenzamide

2.4 Create Date
2018-01-29
3 Chemical and Physical Properties
Molecular Weight 630.8 g/mol
Molecular Formula C32H47FN6O4S
XLogP34.3
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count10
Rotatable Bond Count11
Exact Mass630.33635334 g/mol
Monoisotopic Mass630.33635334 g/mol
Topological Polar Surface Area116 Ų
Heavy Atom Count44
Formal Charge0
Complexity1040
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

API SUPPLIERS

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API Reference Price

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28-Mar-2022
15-Oct-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: 12600

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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https://www.globenewswire.com/news-release/2026/01/12/3216705/0/en/Syndax-Reports-Preliminary-2025-Financial-Highlights-and-Provides-Business-Updates-at-the-44th-Annual-J-P-Morgan-Healthcare-Conference.html

GLOBENEWSWIRE
12 Jan 2026

https://www.globenewswire.com/news-release/2026/01/07/3214380/0/en/Syndax-and-World-Orphan-Drug-Alliance-to-Launch-a-Multi-Regional-Managed-Access-Program-Expanding-Access-to-Revuforj-revumenib-Outside-the-U-S.html

GLOBENEWSWIRE
07 Jan 2026

https://www.globenewswire.com/news-release/2025/12/12/3204567/0/en/Revuforj-revumenib-Named-Best-New-Drug-at-the-Scrip-Awards-2025.html

GLOBENEWSWIRE
12 Dec 2025

https://www.globenewswire.com/news-release/2025/12/08/3201378/0/en/Syndax-Highlights-Leadership-in-Menin-Inhibition-at-ASH-2025-with-Multiple-Revuforj-revumenib-Presentations-Spanning-the-Acute-Leukemia-Treatment-Continuum.html

GLOBENEWSWIRE
08 Dec 2025

https://www.globenewswire.com/news-release/2025/11/03/3179405/0/en/Syndax-to-Host-ASH-Investor-Event-in-Person-and-via-Webcast-on-December-8-2025.html

GLOBENEWSWIRE
03 Nov 2025

https://www.globenewswire.com/news-release/2025/11/03/3179404/0/en/Syndax-Announces-Compelling-Revuforj-revumenib-and-Niktimvo-axatilimab-csfr-Data-Accepted-for-Presentation-at-ASH-2025.html

GLOBENEWSWIRE
03 Nov 2025

Patents & EXCLUSIVITIES

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Looking for 2169919-21-3 / Revumenib API manufacturers, exporters & distributors?

Revumenib manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Revumenib 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 Revumenib manufacturer or Revumenib supplier for your needs.

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

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

API | Excipient name

Revumenib

Synonyms

Sndx-5613, 2169919-21-3, Lz0m43nnf2, Sndx5613, Sndx-5613 free base, N-ethyl-2-[4-[7-[[4-(ethylsulfonylamino)cyclohexyl]methyl]-2,7-diazaspiro[3.5]nonan-2-yl]pyrimidin-5-yl]oxy-5-fluoro-n-propan-2-ylbenzamide

Cas Number

2169919-21-3

Unique Ingredient Identifier (UNII)

LZ0M43NNF2

About Revumenib

Revumenib is an orally bioavailable protein-protein interaction (PPI) inhibitor of the menin-mixed lineage leukemia (MLL; myeloid/lymphoid leukemia; KMT2A) proteins, with potential antineoplastic activity. Upon oral administration, revumenib targets and binds to the nuclear protein menin, thereby preventing the interaction between the two proteins menin and MLL and the formation of the menin-MLL complex. This reduces the expression of downstream target genes and results in an inhibition of the proliferation of MLL-rearranged leukemic cells. The menin-MLL complex plays a key role in the survival, growth, transformation and proliferation of certain kinds of leukemia cells.

Revumenib Manufacturers

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

Revumenib Suppliers

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

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

Revumenib 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 Revumenib as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Revumenib GMP

Revumenib 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 Revumenib 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 Revumenib GMP manufacturer or Revumenib GMP API supplier for your needs.

Revumenib CoA

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

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

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