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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 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 Formula	C₂₅H₃₀N₂O₄
Molecular Weight	422.5 g/mol
XLogP3	1.8
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	7
Exact Mass	422.22055744 g/mol
Monoisotopic Mass	422.22055744 g/mol
Topological Polar Surface Area	74.8 Å²
Heavy Atom Count	31
Formal Charge	0
Complexity	594
Isotope Atom Count	0
Defined Atom Stereocenter Count	2
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

NDC API

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Novartis Pharma Schweizerhalle AG

Switzerland

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Drugs in Development

01 Novartis Pharmaceuticals Corporation

Switzerland

Switzerland

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10 Novartis Pharmaceuticals Corporation

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Digital Content

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DATA COMPILATION #PharmaFlow

FDA approvals slump 19% in H1 2024; NASH, COPD, PAH get new treatment options

The first half of 2024 saw a significant slowdown in approvals of new drugs and biologics by the US Food and Drug Administration (FDA) compared to the same period last year.FDA’s Center for Drug Evaluation and Research (CDER) approved 21 drugs in H1 2024, reflecting a 19 percent decrease from the 26 approvals granted in H1 2023. Of them, 81 percent (17) were first-in-class drugs (therapies that use a new and unique mechanism of action), while small molecules made up for 67 percent (14) of the total drugs approved.Similarly, the Center for Biologics Evaluation and Research (CBER) granted approvals to only eight biologics, as compared to 10 in H1 2023.Health Canada also saw a drop in drug approvals as only 10 drugs were okayed in H1 2024, as opposed to 13 approvals in H1 2023.The European Medicines Agency (EMA) saw a marginal rise in drug authorizations at 15 for H1 2024 as compared to 14 approvals in H1 2023. Interestingly, the EMA also saw a surge in pending decisions (applications under review) — from two in H1 2023 to 14 in H1 2024.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available)Merck, Madrigal, Verona bag approvals for breakthrough meds; Lilly’s donanemab okayedThe first half saw some closely watched drugs win regulatory approvals. FDA approved a breakthrough therapy from Merck — Winrevair (sotatercept) — that treats adults with hypertension caused by the constriction of arteries in the lungs, known as pulmonary arterial hypertension (PAH).Merck had acquired Winrevair through its US$ 11.5 billion acquisition of Acceleron Pharma in 2021. The therapy is set to generate nearly US$ 3 billion in global peak sales by 2028. Another breakthrough therapy approved in H1 2024 is Madrigal’s Rezdiffra (resmetirom), the first FDA-approved treatment for adults with the common fatty liver disease — nonalcoholic steatohepatitis (NASH). Rezdiffra is expected to touch sales of US$ 2.1 billion by 2028.The agency also approved the first maintenance treatment for chronic obstructive pulmonary disease (COPD) in over 20 years — Verona’s Ohtuvayre. The drug has a novel mechanism of action and is the first inhaled maintenance treatment for COPD. Approved in June by the FDA, Ohtuvayre is forecast to bring in global sales of US$ 1.5 billion by 2030.The approval of Eli Lilly’s donanemab was surprisingly delayed, and finally came through on July 2 after an FDA advisory committee voted unanimously in favor of its benefits outweighing its risks. To be sold as Kinsula, the Alzheimer's drug is estimated to bring in US$ 2.2 billion in sales by 2028.Across the pond, EMA approved Novo Nordisk’s weekly insulin injection Awiqli (insulin icodec). The replacement insulin in Awiqli acts in the same way as the body’s own insulin and helps glucose enter cells from the blood. Meanwhile, FDA rejected this once-a-week insulin earlier this month and has requested information related to the manufacturing process.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) ImmunityBio, Geron, Day One win approvals for their oncology drugsIn what marks the first approval for ImmunityBio, FDA greenlit Anktiva (nogapendekin alfa inbakicept-pmln) as part of a combination therapy to treat a type of bladder cancer. Anktiva is a next-generation immunotherapy that creates long-term immunity by activating the so-called natural killer (NK) cells and T-cells. It will compete with Merck’s Keytruda. Anktiva’s yearly sales by 2030 are expected to be around US$ 1.7 billion.BeiGene’s PD-1 blocker Tevimbra (tislelizumab) got the go-ahead from the FDA as the treatment for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Tevimbra’s 2028 global sales are forecast to bring in US$ 1.6 billion.FDA signed off on Geron’s Rytelo (imetelstat) for treating transfusion-dependent anemia in patients with low- to intermediate-risk myelodysplastic syndromes (MDS), a group of blood cancers. This was Geron’s maiden approval and Rytelo is expected to bring in US$ 1.3 billion by 2030.Day One Biopharmaceuticals’ Ojemda (tovorafenib) was granted FDA’s accelerated approval to treat certain types of pediatric brain cancer. This is the first FDA approval of a systemic therapy for treating what is the most common form of childhood brain tumor, including fusions. Ojemda is forecast to bring in US$ 1 billion in sales by 2030.FDA granted accelerated approval to Amgen’s Imdelltra (tarlatamab-dlle) for adults in advanced stages of small cell lung cancer (SCLC) that has proven to be hard to treat or has worsened despite platinum-based chemotherapy. Imdelltra is expected to bring in annual sales of US$ 975 million by 2030.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) Infectious disease drugs from Basilea, Merck, rare disease med from Ipsen bag approvalsAfter oncology, infections and infectious diseases, and rare diseases were the two therapeutic areas that saw the second and third most approvals, respectively. FDA approved Basilea Pharmaceutica’s Zevtera (ceftobiprole medocaril sodium for injection), an antibiotic for bacterial infections including multidrug-resistant strains.The US agency also approved Merck’s next-generation vaccine designed to protect adults from pneumococcus bacteria that causes serious illnesses and pneumonia. The jab, known as Capvaxive, helped produce an immune response against all 21 variations (serotypes) of the bacteria that it targeted. These 21 strains account for about 85 percent of invasive pneumococcal disease cases in adults aged 65 and above. FDA also approved Moderna’s mRESVIA, a messenger RNA-based (mRNA) respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by the syncytial virus. This is the first non-Covid mRNA vaccine to be approved in the US.The agency granted accelerated approval to Ipsen’s Iqirvo (elafibranor) to treat primary biliary cholangitis (PBC), a rare liver disease. This is the first new medicine approved in nearly a decade for the treatment of PBC. Orchard Therapeutics’ Lenmeldy secured FDA approval to become the first gene therapy in the US for a rare pediatric disorder, known as metachromatic leukodystrophy (MLD). The debilitating hereditary disease affects the brain and the nervous system and causes loss of cognitive and motor functions and early death.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) Our viewThe increased momentum of drug approvals witnessed after the pandemic appears to have slowed down, but what’s encouraging is the increase in first-in-class therapies, cancer drugs and promising new treatment options for a range of conditions such as PAH, NASH, and COPD.The second half has already kicked off with the approval of Lilly’s donanemab. And there are several pathbreaking drugs likely to be approved soon, such as Karuna Therapeutics’ schizophrenia drug KarXT and BridgeBio’s heart drug acoramidis. There is every possibility that new drug approvals will spring back up in H2 2024.

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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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IPTACOPAN HYDROCHLORIDE

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ACTIVE PHARMA INGREDIENTS

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2 DATA COMPILATION #PharmaFlow

2 STOCK RECAP #PipelineProspector

22 NEWS #PharmaBuzz

PATENTS & EXCLUSIVITIES

5 US Patents

3 US Exclusivities

ACTIVE PHARMA INGREDIENTS

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MARKET PLACE

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