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Chemistry

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Also known as: Lnp023, 1644670-37-0, Lnp-023, Iptacopan [inn], Iptacopan [usan], Nvp-lnp023-nx
Molecular Formula
C25H30N2O4
Molecular Weight
422.5  g/mol
InChI Key
RENRQMCACQEWFC-UGKGYDQZSA-N
FDA UNII
8E05T07Z6W

Iptacopan Hydrochloride
Iptacopan is an orally available, small-molecule inhibitor of complement factor B (FB) with potential immunomodulatory activity. Upon administration, iptacopan binds to FB and prevents the formation of the alternative pathway (AP) C3-convertase (C3bBb). This limits the cleavage of C3 to the active fragment C3b and may prevent C3b-mediated extravascular hemolysis in certain complement-driven disorders such as paroxysmal nocturnal hemoglobinuria (PNH).
1 2D Structure

Iptacopan Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-[(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl]benzoic acid
2.1.2 InChI
InChI=1S/C25H30N2O4/c1-4-31-19-10-12-27(22(14-19)17-5-7-18(8-6-17)25(28)29)15-21-20-9-11-26-24(20)16(2)13-23(21)30-3/h5-9,11,13,19,22,26H,4,10,12,14-15H2,1-3H3,(H,28,29)/t19-,22-/m0/s1
2.1.3 InChI Key
RENRQMCACQEWFC-UGKGYDQZSA-N
2.1.4 Canonical SMILES
CCOC1CCN(C(C1)C2=CC=C(C=C2)C(=O)O)CC3=C(C=C(C4=C3C=CN4)C)OC
2.1.5 Isomeric SMILES
CCO[C@H]1CCN([C@@H](C1)C2=CC=C(C=C2)C(=O)O)CC3=C(C=C(C4=C3C=CN4)C)OC
2.2 Other Identifiers
2.2.1 UNII
8E05T07Z6W
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Lnp023

2. 1644670-37-0

3. Lnp-023

4. Iptacopan [inn]

5. Iptacopan [usan]

6. Nvp-lnp023-nx

7. Nvp-lnp023

8. 8e05t07z6w

9. 4-[(2s,4s)-4-ethoxy-1-[(5-methoxy-7-methyl-1h-indol-4-yl)methyl]piperidin-2-yl]benzoic Acid

10. 4-[(2~{s},4~{s})-4-ethoxy-1-[(5-methoxy-7-methyl-1~{h}-indol-4-yl)methyl]piperidin-2-yl]benzoic Acid

11. Benzoic Acid, 4-((2s,4s)-4-ethoxy-1-((5-methoxy-7-methyl-1h-indol-4-yl)methyl)-2-piperidinyl)-

12. Benzoic Acid, 4-[(2s,4s)-4-ethoxy-1-[(5-methoxy-7-methyl-1h-indol-4-yl)methyl]-2-piperidinyl]-

13. Iptacopan [who-dd]

14. Unii-8e05t07z6w

15. Chembl4594448

16. Schembl16400416

17. Gtpl10710

18. Us9682968, Example-26a

19. Bdbm160475

20. Ex-a5728

21. Who 11259

22. Zinc223246892

23. At30389

24. Compound 41 [pmid: 32073845]

25. Hy-127105

26. Cs-0093107

27. A935227

28. 4-((2s,4s)-(4-ethoxy-1-((5-methoxy-7-methyl-1h-indol-4-yl)methyl)piperidin-2-yl))benzoic Acid

29. 4-((2s,4s)-4-ethoxy-1-((5-methoxy-7-methyl-1h-indol-4-yl)methyl)piperidin-2-yl)benzoicacid

30. Jgq

2.4 Create Date
2015-02-16
3 Chemical and Physical Properties
Molecular Weight 422.5 g/mol
Molecular Formula C25H30N2O4
XLogP31.8
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count5
Rotatable Bond Count7
Exact Mass422.22055744 g/mol
Monoisotopic Mass422.22055744 g/mol
Topological Polar Surface Area74.8 Ų
Heavy Atom Count31
Formal Charge0
Complexity594
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

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IPTACOPAN HYDROCHLORIDE

Brand Name : FABHALTA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 200MG BASE

Packaging :

Approval Date : 2023-12-05

Application Number : 218276

Regulatory Info : RX

Registration Country : USA

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IPTACOPAN HYDROCHLORIDE

Brand Name : FABHALTA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 200MG BASE

Approval Date : 2023-12-05

Application Number : 218276

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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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. 

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STOCK RECAP #PipelineProspector

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Pipeline Prospector Aug 2024: Otsuka buys Jnana, Lilly’s market cap gains by over US$ 108 bn post new guidance
As summer draws to a close, pharma and biotech indices posted their fourth consecutive month in the green. The Nasdaq Biotechnology Index (NBI) rose 1.3 percent from 4,821.49 to 4,882 in August and the SPDR S&P Biotech ETF (XBI) index gained 1.7 percent from 99.53 to 101.26. The S&P Biotechnology Select Industry Index (SPSIBI) saw a 2.3 percent increase to 7,897.85 from 7,717 posted in July-end. Over the last four months, NBI, XBI, and SPSIBI have rallied 17 percent, 19 percent, and 20 percent, respectively.Amongst the notable negative news, the US Food and Drug Administration (FDA) declined to approve an application of MDMA, commonly known as ecstasy, to treat post-traumatic stress disorder (PTSD). Lykos Therapeutics, the company behind this application, received a complete response letter citing concerns about the trial. Access the Pipeline Prospector Dashboard for August 2024 Newsmakers (Free Excel)Otsuka buys Jnana for up to US$ 1.1 bn; Merck inks US$ 1.3 bn deal with China’s CuronAugust saw several acquisitions and deals. Japan’s Otsuka Pharmaceutical said it is acquiring clinical-stage biotech Jnana Therapeutics through a potential US$ 1.1 billion deal. This includes a payment of US$ 800 million to Jnana’s shareholders on completion of the acquisition, and an additional US$ 325 million in milestone payments. Merck has evinced interest in the growing field of bispecific antibodies by paying China-based Curon US$ 700 million upfront, with an additional US$ 600 million in milestone payments, for the rights to CN201, an experimental cancer med in early-stage trials for treating non-Hodgkin’s lymphoma and B-cell acute lymphocytic leukemia.Roche, via its subsidiary Genentech, has secured exclusive rights to molecules from Sangamo Therapeutics designed to repress the gene that makes “tau,” a protein many scientists believe is a driver of Alzheimer’s disease. The potential US$ 1.95 billion deal comprises other novel genomic medicines for neurodegenerative diseases.Denmark’s Adcendo acquired global rights (excluding Greater China) to Multitude Therapeutics' first-in-class antibody-drug-conjugate (ADC) candidate for up to US$ 1 billion. The ADC targets tissue factor (TF) highly expressed in various cancers including lung, colorectal, cervical, esophageal, head and neck, bladder, and some gastrointestinal cancers, but limited in normal tissues. The candidate, ADCE-T02, is a highly differentiated anti-TF ADC.In other deals, Instil Bio agreed to pay up to US$ 2 billion to China’s ImmuneOnco Biopharmaceuticals for two clinical-stage cancer candidates. Similarly, Eisai inked a deal with SEED Therapeutics worth up to US$ 1.5 billion to develop novel drugs for neurodegenerative diseases and cancer. Access the Pipeline Prospector Dashboard for August 2024 Newsmakers (Free Excel) Gilead’s US$ 4.3bn CymaBay bet pays off; Adaptimmune’s Tecelra becomes first-ever TCR gene therapyThe month also saw several significant drug approvals. Gilead’s Livdelzi gained FDA’s accelerated approval for primary biliary cholangitis (PBC), an inflammatory liver disease. This approval validates Gilead’s US$ 4.3 billion acquisition of CymaBay and positions the once-daily pill as a potential challenger to the current PBC standard of care.Novartis’ Fabhalta also gained accelerated approval for reducing excess protein in the urine of patients with primary immunoglobulin A nephropathy (IgAN), addressing an important aspect of kidney disease management.Adaptimmune’s Tecelra received accelerated approval from the FDA as the first-ever T cell receptor (TCR) gene therapy. It was greenlit for a rare type of cancer — synovial sarcoma — that often affects young people.J&J’s high hopes for Rybrevant got validated when FDA approved it for use in combination with its new drug Lazcluze to treat a kind of non-small cell lung cancer (NSCLC). This is the only chemotherapy-free regimen that has shown superior progression-free survival as compared to AstraZeneca’s Tagrisso, the current standard of care in the first-line setting.Meanwhile, Astra’s other blockbuster cancer drug Imfinzi received FDA’s approval as an additional treatment after surgery for a type of NSCLC, expanding its use in the treatment paradigm.Servier’s Voranigo became the first and only treatment in the US for a certain kind of brain tumor, offering a once-daily pill option for patients with grade 2 IDH-mutant glioma. Additionally in oncology, GSK’s Jemperli received a broad US label expansion for first-line treatment of endometrial cancer. Citius’ Lymphir received FDA approval for relapsed or refractory cutaneous T-cell lymphoma.ARS Pharmaceuticals’ EURneffy and Neffy became the first nasal spray alternatives to EpiPen for severe allergic reactions in Europe and the US, respectively. This represents a new era in needle-free emergency allergy treatment.To deal with a surge in Covid cases in the US, FDA approved updated versions of Pfizer and BioNTech’s Comirnaty, Moderna’s Spikevax and Novavax's jab that target a strain called KP.2.that target a strain called KP.2. Access the Pipeline Prospector Dashboard for August 2024 Newsmakers (Free Excel) Lilly’s market cap surges US$ 108 bn post Q2 results; Bavarian Nordic’s stock jumps 42%Eli Lilly announced its second-quarter results last month. Its Q2 revenue increased 36 percent year-on-year due to its diabetes and obesity meds Mounjaro and Zepbound and breast cancer med Verzenio. It prompted Lilly to raise its 2024 revenue guidance by US$ 3 billion. Lilly now expects between US$ 45.4 billion and US$ 46.6 billion in 2024 revenue. The news led to a 14 percent rise in its stock, as it gained over US$ 108 billion in market capitalization. The stock hit an all-time high of US$ 972.53 on August 22. Lilly said tirzepatide (Zepbound and Mounjaro) slashed the risk of developing type 2 diabetes in overweight or obese adults with pre-diabetes by 94 percent. One in three adults in the US, or around 98 million Americans, have pre-diabetes. A late-stage trial also showed tirzepatide reduced the risk of hospitalization or death due to heart failure by 38 percent.The stock of Bavarian Nordic, which makes the monkey pox vaccine Jynneos, gained 42 percent in August after the World Health Organization declared a global health emergency over the mpox outbreak in Africa. As the month drew to a close, FDA granted expanded approval to Emergent BioSolutions’ smallpox vaccine — ACAM2000 — for use in people at high risk of mpox infection. This makes Emergent’s shot the second approved vaccine against mpox in the US after Jynneos.In trials, Bayer posted a key win with Kerendia showing it can reduce the risk of cardiovascular death, and first and recurrent heart failure events in a phase 3 trial. Access the Pipeline Prospector Dashboard for August 2024 Newsmakers (Free Excel) Our viewDuring August, the pharmaceutical industry’s resilience was on full display. A surge in Lilly’s market cap by US$ 108 billion underscores the commercial potential of cutting-edge therapies. And we hope to see more of such successes on the bourses in the coming months. Access the Pipeline Prospector Dashboard for August 2024 Newsmakers (Free Excel) 

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05 Sep 2024

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Brand Name : Fabhalta

Iptacopan

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Iptacopan

Main Therapeutic Indication : Rare Diseases and Disorders

Currency : USD

2024 Revenue in Millions : 129

2023 Revenue in Millions : 1

Growth (%) : 12,800

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US Patents

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IPTACOPAN HYDROCHLORIDE

US Patent Number : 12285422

Drug Substance Claim :

Drug Product Claim :

Application Number : 218276

Patent Use Code : U-4181

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-08-30

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IPTACOPAN HYDROCHLORIDE

US Patent Number : 10093663

Drug Substance Claim :

Drug Product Claim :

Application Number : 218276

Patent Use Code : U-4161

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-07-14

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US Patent Number : 11951101

Drug Substance Claim :

Drug Product Claim :

Application Number : 218276

Patent Use Code : U-3895

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2041-07-15

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US Patent Number : 11723901

Drug Substance Claim :

Drug Product Claim :

Application Number : 218276

Patent Use Code : U-3980

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-08-30

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US Patent Number : 10093663

Drug Substance Claim :

Drug Product Claim :

Application Number : 218276

Patent Use Code : U-3980

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-07-14

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US Patent Number : 9682968

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 218276

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-07-14

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US Patent Number : 11603363

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 218276

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2041-05-25

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Exclusivity Code : I-949

Exclusivity Expiration Date : 2027-08-07

Application Number : 218276

Product Number : 1

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Exclusivity Code : I-963

Exclusivity Expiration Date : 2028-03-20

Application Number : 218276

Product Number : 1

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IPTACOPAN HYDROCHLORIDE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2028-12-05

Application Number : 218276

Product Number : 1

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IPTACOPAN HYDROCHLORIDE

Exclusivity Code : ODE-456

Exclusivity Expiration Date : 2030-12-05

Application Number : 218276

Product Number : 1

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API | Excipient name

Iptacopan Hydrochloride

Synonyms

Lnp023, 1644670-37-0, Lnp-023, Iptacopan [inn], Iptacopan [usan], Nvp-lnp023-nx

Cas Number

1644670-37-0

Unique Ingredient Identifier (UNII)

8E05T07Z6W

About Iptacopan Hydrochloride

Iptacopan is an orally available, small-molecule inhibitor of complement factor B (FB) with potential immunomodulatory activity. Upon administration, iptacopan binds to FB and prevents the formation of the alternative pathway (AP) C3-convertase (C3bBb). This limits the cleavage of C3 to the active fragment C3b and may prevent C3b-mediated extravascular hemolysis in certain complement-driven disorders such as paroxysmal nocturnal hemoglobinuria (PNH).

Iptacopan Manufacturers

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

Iptacopan Suppliers

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

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

Iptacopan 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 Iptacopan as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Iptacopan GMP

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

Iptacopan CoA

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

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

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