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Chemistry

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Also known as: 1075236-89-3, Gsk2140944, Gsk-2140944, Gsk 2140944, Dvf0pr037d, 3h,8h-2a,5,8a-triazaacenaphthylene-3,8-dione, 2-((4-(((3,4-dihydro-2h-pyrano(2,3-c)pyridin-6-yl)methyl)amino)-1-piperidinyl)methyl)-1,2-dihydro-, (2r)-
Molecular Formula
C24H28N6O3
Molecular Weight
448.5  g/mol
InChI Key
PZFAZQUREQIODZ-LJQANCHMSA-N
FDA UNII
DVF0PR037D

Gepotidacin
Gepotidacin has been used in trials studying the treatment of Gonorrhea, Infections, Bacterial, and Infections, Respiratory Tract.
1 2D Structure

Gepotidacin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(3R)-3-[[4-(3,4-dihydro-2H-pyrano[2,3-c]pyridin-6-ylmethylamino)piperidin-1-yl]methyl]-1,4,7-triazatricyclo[6.3.1.04,12]dodeca-6,8(12),9-triene-5,11-dione
2.1.2 InChI
InChI=1S/C24H28N6O3/c31-22-4-3-20-24-29(22)15-19(30(24)23(32)13-27-20)14-28-7-5-17(6-8-28)25-11-18-10-16-2-1-9-33-21(16)12-26-18/h3-4,10,12-13,17,19,25H,1-2,5-9,11,14-15H2/t19-/m1/s1
2.1.3 InChI Key
PZFAZQUREQIODZ-LJQANCHMSA-N
2.1.4 Canonical SMILES
C1CC2=CC(=NC=C2OC1)CNC3CCN(CC3)CC4CN5C(=O)C=CC6=C5N4C(=O)C=N6
2.1.5 Isomeric SMILES
C1CC2=CC(=NC=C2OC1)CNC3CCN(CC3)C[C@@H]4CN5C(=O)C=CC6=C5N4C(=O)C=N6
2.2 Other Identifiers
2.2.1 UNII
DVF0PR037D
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Gsk2140944

2.3.2 Depositor-Supplied Synonyms

1. 1075236-89-3

2. Gsk2140944

3. Gsk-2140944

4. Gsk 2140944

5. Dvf0pr037d

6. 3h,8h-2a,5,8a-triazaacenaphthylene-3,8-dione, 2-((4-(((3,4-dihydro-2h-pyrano(2,3-c)pyridin-6-yl)methyl)amino)-1-piperidinyl)methyl)-1,2-dihydro-, (2r)-

7. (2r)-2-[(4-{[(3,4-dihydro-2h-pyrano[2,3-c]pyridin- 6-yl)methyl]amino}piperidin-1-yl)methyl]-1,2-dihydro- 3h,8h-2a,5,8a-triazaacenaphthylene-3,8-dione

8. (3~{r})-3-[[4-(3,4-dihydro-2~{h}-pyrano[2,3-c]pyridin-6-ylmethylamino)piperidin-1-yl]methyl]-1,4,7-triazatricyclo[6.3.1.0^{4,12}]dodeca-6,8(12),9-triene-5,11-dione

9. (3r)-3-[[4-(3,4-dihydro-2h-pyrano[2,3-c]pyridin-6-ylmethylamino)piperidin-1-yl]methyl]-1,4,7-triazatricyclo[6.3.1.04,12]dodeca-6,8(12),9-triene-5,11-dione

10. Gepotidacin [usan:inn]

11. Unii-dvf0pr037d

12. 3h,8h-2a,5,8a-triazaacenaphthylene-3,8-dione, 2-[[4-[[(3,4-dihydro-2h-pyrano[2,3-c]pyridin-6-yl)methyl]amino]-1-piperidinyl]methyl]-1,2-dihydro-, (2r)-

13. Jhn

14. Gepotidacin [inn]

15. Gepotidacin (usan/inn)

16. Gepotidacin [usan]

17. Gepotidacin [who-dd]

18. Schembl3332319

19. Chembl3317856

20. Gtpl10817

21. Dtxsid501028208

22. Bdbm50050549

23. Gsk 2140944e

24. Cs-6531

25. Db12134

26. Hy-16742

27. D10878

28. A857306

29. Q19597285

2.4 Create Date
2008-12-15
3 Chemical and Physical Properties
Molecular Weight 448.5 g/mol
Molecular Formula C24H28N6O3
XLogP30.1
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count7
Rotatable Bond Count5
Exact Mass448.22228878 g/mol
Monoisotopic Mass448.22228878 g/mol
Topological Polar Surface Area90.4 Ų
Heavy Atom Count33
Formal Charge0
Complexity893
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

Treatment of uncomplicated urogenital gonorrhea


Treatment of uncomplicated urinary tract infections


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Topoisomerase Inhibitors

Compounds that inhibit the activity of DNA TOPOISOMERASES. (See all compounds classified as Topoisomerase Inhibitors.)


Drugs in Development

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  • Development Update

Details:

Blujepa (gepotidacin) is the first in a new class of oral antibiotics which inhibits topoisomerase II/IV. It is approved for the treatment of uncomplicated urinary tract infections.


Lead Product(s): Gepotidacin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Blujepa

Study Phase: Approved FDFProduct Type: Antibiotic

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 25, 2025

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01

GSK

United Kingdom
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BPI Europe
Not Confirmed

GSK

United Kingdom
arrow
BPI Europe
Not Confirmed

Details : Blujepa (gepotidacin) is the first in a new class of oral antibiotics which inhibits topoisomerase II/IV. It is approved for the treatment of uncomplicated urinary tract infections.

Product Name : Blujepa

Product Type : Antibiotic

Upfront Cash : Inapplicable

March 25, 2025

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  • Development Update

Details:

GSK 2140944 (gepotidacin) is a potential first-in-class oral antibiotic which inhibits bacterial DNA replication, with a novel mechanism of action for uncomplicated urogenital gonorrhoea.


Lead Product(s): Gepotidacin

Therapeutic Area: Infections and Infectious Diseases Brand Name: GSK 2140944

Study Phase: Phase IIIProduct Type: Antibiotic

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 17, 2024

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02

GSK

United Kingdom
arrow
BPI Europe
Not Confirmed

GSK

United Kingdom
arrow
BPI Europe
Not Confirmed

Details : GSK 2140944 (gepotidacin) is a potential first-in-class oral antibiotic which inhibits bacterial DNA replication, with a novel mechanism of action for uncomplicated urogenital gonorrhoea.

Product Name : GSK 2140944

Product Type : Antibiotic

Upfront Cash : Inapplicable

April 17, 2024

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  • Development Update

Details:

GSK 2140944 (gepotidacin) is an investigational bactericidal antibiotic inhibiting bacterial DNA replication by a novel mechanism, evaluated for treating uncomplicated urogenital gonorrhea.


Lead Product(s): Gepotidacin

Therapeutic Area: Infections and Infectious Diseases Brand Name: GSK 2140944

Study Phase: Phase IIIProduct Type: Antibiotic

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 26, 2024

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03

GSK

United Kingdom
arrow
BPI Europe
Not Confirmed

GSK

United Kingdom
arrow
BPI Europe
Not Confirmed

Details : GSK 2140944 (gepotidacin) is an investigational bactericidal antibiotic inhibiting bacterial DNA replication by a novel mechanism, evaluated for treating uncomplicated urogenital gonorrhea.

Product Name : GSK 2140944

Product Type : Antibiotic

Upfront Cash : Inapplicable

February 26, 2024

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  • Development Update

Details:

GSK 2140944 (gepotidacin) is an investigational bactericidal that inhibits bacterial DNA replication by a novel mechanism of action and binding site and provides well-balanced inhibition of two different Type II topoisomerase enzymes.


Lead Product(s): Gepotidacin

Therapeutic Area: Infections and Infectious Diseases Brand Name: GSK 2140944

Study Phase: Phase IIIProduct Type: Antibiotic

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 15, 2023

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04

GSK

United Kingdom
arrow
BPI Europe
Not Confirmed

GSK

United Kingdom
arrow
BPI Europe
Not Confirmed

Details : GSK 2140944 (gepotidacin) is an investigational bactericidal that inhibits bacterial DNA replication by a novel mechanism of action and binding site and provides well-balanced inhibition of two different Type II topoisomerase enzymes.

Product Name : GSK 2140944

Product Type : Antibiotic

Upfront Cash : Inapplicable

April 15, 2023

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  • Development Update

Details:

The EAGLE-2 and EAGLE-3 trials met primary efficacy endpoint of combined clinical and microbiological resolution following treatment at the Test-Of-Cure visit for gepotidacin (GSK 2140944) v/s nitrofurantoin in patients with uUTI and a uropathogen sensitive to nitrofurantoin.


Lead Product(s): Gepotidacin

Therapeutic Area: Infections and Infectious Diseases Brand Name: GSK 2140944

Study Phase: Phase IIIProduct Type: Antibiotic

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 11, 2022

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05

GSK

United Kingdom
arrow
BPI Europe
Not Confirmed

GSK

United Kingdom
arrow
BPI Europe
Not Confirmed

Details : The EAGLE-2 and EAGLE-3 trials met primary efficacy endpoint of combined clinical and microbiological resolution following treatment at the Test-Of-Cure visit for gepotidacin (GSK 2140944) v/s nitrofurantoin in patients with uUTI and a uropathogen sensit...

Product Name : GSK 2140944

Product Type : Antibiotic

Upfront Cash : Inapplicable

March 11, 2022

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INTERMEDIATE SUPPLIERS

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Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

CAS Number : 13035-19-3

End Use API : Gepotidacin

About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...

Tagoor Laboratories
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DATA COMPILATION #PharmaFlow

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Top first-in-class drug candidates of 2025: Ionis’ donidalorsen, Sanofi’s fitusiran, Cytokinetics’ aficamten await FDA approval
First‑in‑class drugs are therapies with entirely new approaches that improve patient outcomes and fundamentally change treatment paradigms.This week, PharmaCompass brings a compilation of 2025’s most promising first-in-class drug candidates. With their US Food and Drug Administration (FDA) action dates in 2025, many of these drugs, once approved, hold the potential of becoming blockbusters.Ionis’ donidalorsen, Sanofi’s fitusiran, Cytokinetics’ aficamten poised to transform patient careIonis’ donidalorsen is an exciting candidate designed to tackle hereditary angioedema (HAE), a rare condition marked by unpredictable and potentially life‑threatening swelling episodes.This novel antisense oligonucleotide works by “silencing” the messenger RNA that codes for prekallikrein — a protein that triggers inflammation leading to swelling. Instead of blocking a protein once it’s made, donidalorsen stops the cell from producing it in the first place. This precision approach could mean fewer infusions and reduced side effects compared to traditional treatments.Another promising candidate is Sanofi and Alnylam Pharmaceuticals’ fitusiran. It employs the technology of small interfering RNA (siRNA) to lower levels of antithrombin — a natural protein that, when in excess, can impair the blood’s ability to clot. By reducing antithrombin, fitusiran rebalances the blood’s clotting process in patients with hemophilia A and B.Similarly, Cytokinetics’ aficamten is designed to treat obstructive hypertrophic cardiomyopathy (oHCM), a condition in which the heart muscle becomes abnormally thick, obstructing blood flow. Aficamten works by inhibiting cardiac myosin, a protein that drives heart muscle contraction. This helps relieve symptoms like shortness of breath and chest pain. If approved, aficamten is expected to rake in annual sales of US$ 2.8 billion by 2030.UroGen, J&J’s candidates eye US$ 5 bn markets; AbbVie, Summit’s meds target lung cancerUroGen Pharma’s UGN‑102 is poised to redefine the treatment of non‑muscle‑invasive bladder cancer. This innovative formulation uses a reverse thermal gel technology that transforms from a liquid into a gel once inside the bladder. This change ensures that the chemotherapeutic agent, mitomycin, remains in contact with the bladder lining for a longer period, increasing its effectiveness at eradicating cancer cells and reducing the risk of recurrence.For patients, UGN‑102 could mean a non‑surgical, outpatient treatment option that is less invasive than traditional surgical methods. If approved, UGN-102 could address a US market of approximately 82,000 patients annually, translating into a market opportunity exceeding US$ 5 billion, according to company estimates.Johnson & Johnson’s nipocalimab is a new treatment aimed at helping people with autoimmune diseases — a group of conditions where the body’s defense system mistakenly attacks its own healthy cells. Nipocalimab works by blocking the neonatal Fc receptor (FcRn), thereby lowering the levels of pathogenic antibodies that drive many autoimmune disorders. J&J had acquired this FcRn blocker in 2020 as part of its US$ 6.5 billion takeover of Momenta Pharmaceuticals. J&J is trialing the drug in as many as 10 indications and expects peak annual sales in excess of US$ 5 billion.AbbVie’s antibody-drug conjugate (ADC), telisotuzumab vedotin, is designed as a “guided-missile” to deliver toxic drugs directly to cancer cells while sparing healthy tissues. Telisotuzumab vedotin targets c‑Met, a receptor that is over-expressed in certain cancers such as non‑small cell lung cancer (NSCLC). There are currently no approved anti-cancer therapies specifically for c-Met over-expressing NSCLC.Summit Therapeutics’ ivonescimab is a cutting‑edge bispecific antibody designed specifically for NSCLC. Unlike traditional therapies that target a single molecule, ivonescimab binds simultaneously to a tumor-specific antigen on cancer cells and to a receptor on T cells, effectively bringing these two together so the body’s own immune system can recognize and attack the tumor. This dual engagement strategy helps overcome common mechanism tumors.Insmed’s Brensocatib is an innovative, first‐in‐class oral inhibitor of dipeptidyl peptidase‑1 (DPP‑1) that targets a key step in the inflammatory cascade. DPP‑1 is responsible for activating neutrophil serine proteases — enzymes that, when overactive, can cause significant lung tissue damage in conditions such as non‑cystic fibrosis bronchiectasis. Brensocatib is expected to clock annual sales of US$ 2.8 billion by 2030.Gepotidacin, an investigational antibiotic developed by GSK, is poised to make a significant impact in the treatment of uncomplicated urinary tract infections (uUTIs) and urogenital gonorrhea. If approved, it would be the first oral antibiotic in a new class for uUTIs in over two decades.Arrowhead, Regenxbio, Ultragenyx address rare, genetic diseasesArrowhead Pharmaceuticals is developing an innovative gene-targeting therapy — plozasiran. This drug uses RNA interference (RNAi) to interrupt the gene responsible for producing apolipoprotein C‑III (APOC3), a protein that regulates blood triglyceride levels. For people with severe hypertriglyceridemia or familial chylomicronemia syndrome (FCS) — a severe and rare genetic disease for which there are currently no FDA‑approved treatments — high triglyceride levels can lead to pancreatitis and other serious cardiovascular issues. Regenxbio’s RGX‑121 is a one‑time gene therapy candidate for Hunter syndrome (MPS 2), a rare, inherited disorder that causes progressive neurological decline. The therapy uses a harmless virus to deliver a functional copy of the gene encoding iduronate‑2‑sulfatase (I2S) directly into the central nervous system. By restoring the missing enzyme, RGX‑121 aims to slow or even reverse the harmful buildup of substances in the brain that drive the disease’s progression.Another promising candidate is Ultragenyx Pharmaceuticals’ one-time intravenous gene therapy UX111 for Sanfilippo syndrome type A (MPS 3A). This devastating disorder, which leads to severe neurodegeneration in children, currently has no effective treatment. UX111 uses an adeno‑associated virus (AAV) to deliver a working copy of the SGSH gene, the deficiency of which is responsible for the disease. By enabling the body to produce the missing enzyme, UX111 holds the promise of slowing or even halting the progression of neurodegeneration.Our viewThis year has already seen several first-in-class approvals, such as Vertex’s suzetrigine (Journavx), a pioneering non‐opioid analgesic redefining pain management; SpringWorks’ mirdametinib (Gomekli), a breakthrough MEK inhibitor for a genetic disorder that often leads to the growth of benign tumors along nerves and; AstraZeneca and Daiichi’s ADC datopotamab deruxtecan (Datroway).Despite the volatile political environment in the US and its impact on federal agencies like the FDA, we are hopeful that many of the first-in-class drugs mentioned in this article will make a debut in 2025. 

Impressions: 4743

https://www.pharmacompass.com/radio-compass-blog/top-first-in-class-drug-candidates-of-2025-ionis-donidalorsen-sanofi-s-fitusiran-cytokinetics-aficamten-await-fda-approval

#Phispers by PHARMACOMPASS
27 Feb 2025

STOCK RECAP #PipelineProspector

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Pipeline Prospector March 2025: Trump’s FDA overhaul spooks biotech stocks; Roche, AbbVie, Novo ink obesity drug deals
March ended with news that the top vaccine regulator of the US Food and Drug Administration (FDA), Peter Marks, was forced to resign. This impacted pharma indices adversely. The Nasdaq Biotechnology Index (NBI) dropped 6.22 percent from 4,525.73 in February to 4,244.37 in March. The SPDR S&P Biotech ETF (XBI) fell 8.61 percent from 88.74 to 81.10, and the S&P Biotechnology Select Industry Index (SPSIBI) declined 8.61 percent from 6,914.8 to 6,319.5. The sector has been under pressure ever since US President Donald Trump announced plans to impose potential 25 percent tariffs on pharmaceutical imports. Just last week, Johnson & Johnson committed US$ 55 billion to set up four new manufacturing plants in the US. J&J’s announcement follows Eli Lilly’s US$ 27 billion US investment pledge announced in February. Merck too is deepening its domestic footprint with the inauguration of a new US$ 1 billion, 225,000-square-foot vaccine manufacturing facility in Durham, North Carolina, as part of its broader US $20 billion US investment strategy spanning 2018 to 2028.Trump’s trade policy is also driving corporate decisions. In an opportunistic maneuver, Mallinckrodt and Endo — both emerging from bankruptcy due to opioid litigation — decided to merge via a US$ 6.7 billion deal that strategically leverages their extensive US manufacturing capabilities. The new company will focus on branded drugs, and hopes to benefit from tariffs on imported goods.  Access the Pipeline Prospector Dashboard for March 2025 Newsmakers (Free Excel)  Roche, AbbVie ink US$ 5.3 bn, US$ 2.2 bn deals for amylin-based obesity treatments; AstraZeneca strikes multiple dealsMarch saw competition in the obesity treatment market intensify with multiple pharmaceutical giants making strategic moves. The month witnessed a rise in interest in amylin-based treatments. Amylin is a peptide hormone that plays a role in regulating blood sugar and appetite. The amylin pathway has the potential advantage of reducing fat rather than lean muscle.Roche signed a US$ 5.3 billion agreement with Zealand Pharma for petrelintide, a promising long-acting amylin analog administered weekly through a subcutaneous injection. Zealand will receive an upfront payment of US$ 1.65 billion from Roche. AbbVie marked its entry into the lucrative obesity market through an up to US$ 2.23 billion licensing agreement with Danish biotech firm Gubra for GUB014295, another amylin-targeting drug.Towards the end of the month, Novo Nordisk announced a US$ 1 billion licensing deal with Lexicon Pharmaceuticals for the latter’s experimental obesity drug. Under the terms of the deal, Novo will get worldwide rights to develop, manufacture and commercialize the drug, LX9851, for obesity and associated metabolic disorders.Novo also secured ex-China rights to United Laboratories International Holdings’ UBT251 in a deal worth up to US$ 2 billion. This is a "triple-G" drug that targets three receptors — GLP-1, GIP, and glucagon — involved in regulating blood sugar and appetite.Similarly, Merck entered into a US$ 2 billion-worth agreement with Jiangsu Hengrui Pharmaceuticals for HRS-5346, an oral drug targeting lipoprotein(a) reduction to prevent cardiovascular diseases.In immunology, Sanofi’s US$ 1.9 billion acquisition of Dren Bio’s immunology unit centered around DR-0201, a novel treatment for autoimmune diseases that targets specific immune cells (B-cells) that mistakenly attack healthy cells. Early clinical studies suggest this approach could potentially reset the adaptive immune system, offering sustained remission for patients with refractory conditions like lupus.AstraZeneca has been particularly active this month. Astra announced a US$ 1 billion acquisition of Belgian cell therapy biotech EsoBiotec and a US$ 1.35 billion agreement with Alteogen to develop subcutaneous formulations of its oncology drugs. The acquisition brings AstraZeneca the innovative ENaBL platform, which could transform cell therapy by reducing treatment times from weeks to minutes while significantly lowering manufacturing costs.The British-Swedish drugmaker also announced collaborations with Chinese biotech firms, Harbour BioMed and Syneron Bio, as well as a joint venture with BioKangtai to develop, produce, and market vaccines for respiratory and other infectious diseases.Oncology-focused biopharma Chimerix got acquired by Jazz Pharmaceuticals for US$ 935 million. Its lead candidate dordaviprone is currently under FDA review for treating H3 K27M-mutant diffuse glioma, a rare brain tumor.  Access the Pipeline Prospector Dashboard for March 2025 Newsmakers (Free Excel)  GSK’s Blujepa, Roche’s TNKase mark first breakthroughs in 30 years for uUTI, acute ischemic stroke treatmentsThe month saw two key FDA approvals — GSK’s Blujepa and Roche’s TNKase. GSK’s Blujepa (gepotidacin) is the first new class of oral antibiotics for uncomplicated urinary tract infections (uUTIs) in nearly three decades. The drug, approved for the treatment of uUTIs in female adults and patients aged 12 years and older who weigh at least 40 kg, has a novel mechanism of action that offers hope against certain antibiotic-resistant strains.Similarly, the US approval of Roche’s TNKase (tenecteplase) for acute ischemic stroke marks the first new treatment option for stroke patients in nearly 30 years. Its five-second administration offers a critical advantage in time-sensitive stroke management.Sanofi and Alnylam’s RNAi therapy Qfitlia (fitusiran) became the first approved treatment for both hemophilia A and B. And Novartis’ prostate cancer drug Pluvicto won an expanded approval to treat PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) before taxane-based chemotherapy.Alnylam Pharmaceuticals (stock up 9 percent in March) secured FDA approval for Amvuttra (vutrisiran) to treat cardiomyopathy of wild-type or hereditary ATTR-CM, making it the first medication approved in the US to address both ATTR-CM and polyneuropathy of hereditary transthyretin-mediated amyloidosis.  Access the Pipeline Prospector Dashboard for March 2025 Newsmakers (Free Excel)  Novo’s CagriSema underwhelms in late-stage trial; J&J’s med fails, serving another blow to depression treatment March also saw several high-profile clinical disappointments. Novo Nordisk’s (stock down 23 percent) CagriSema (cagrilintide/semaglutide) delivered underwhelming results in its second late-stage obesity trial. While the drug demonstrated superior weight loss compared to Wegovy, showing 13.7 percent average weight reduction over 68 weeks, market expectations for a breakthrough superior to rival Eli Lilly’s Mounjaro (tirzepatide) were not met.The neurology segment continued to see disappointments, especially in the treatment of depression. J&J’s aticaprant failed in late-stage depression studies for major depressive disorder (MDD), forcing the company to abandon its development for this indication. The disappointing results come on the heels of similar setbacks within the same drug class, most notably with Neumora Therapeutics’ navacaprant.  Access the Pipeline Prospector Dashboard for March 2025 Newsmakers (Free Excel)  Our viewThe pharmaceutical landscape has been undergoing dramatic changes since Trump moved into the White House for a second term. The most significant change for the sector is FDA’s overhaul. For decades, FDA has been the gold standard for drug regulation. The overhaul has changed that.“The FDA as we’ve known it is finished,” former FDA Commissioner Robert Califf said in a social media post. Healthcare investment bankers are already talking about large deals getting stalled as executives grapple with the volatile policy scenario. Given these uncertainties, our sentiments are bearish, at least for the short term.  Access the Pipeline Prospector Dashboard for March 2025 Newsmakers (Free Excel)  

Impressions: 4281

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-march-2025-trump-s-fda-overhaul-spooks-biotech-stocks-roche-abbvie-novo-ink-obesity-drug-deals

#PharmaFlow by PHARMACOMPASS
03 Apr 2025

NEWS #PharmaBuzz

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https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/

PRESS RELEASE
26 Mar 2025

https://www.gsk.com/en-gb/media/press-releases/eagle-1-phase-iii-data-show-potential-for-gepotidacin-as-a-new-oral-treatment-option-for-uncomplicated-gc/

PRESS RELEASE
18 Apr 2024

https://www.biospace.com/article/gsk-posts-positive-phase-iii-gonorrhea-results-for-antibiotic-gepotidacin/

BIOSPACE
27 Feb 2024
GSK halts successful UTI trials early, preps FDA submission
GSK halts successful UTI trials early, preps FDA submission

04 Nov 2022

// James Waldron FIERCEBIOTECH

https://www.fiercebiotech.com/biotech/eagles-have-landed-gsk-halts-successful-uti-trials-early-preps-fda-submission

James Waldron FIERCEBIOTECH
04 Nov 2022

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

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

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

API | Excipient name

Gepotidacin

Synonyms

1075236-89-3, Gsk2140944, Gsk-2140944, Gsk 2140944, Dvf0pr037d, 3h,8h-2a,5,8a-triazaacenaphthylene-3,8-dione, 2-((4-(((3,4-dihydro-2h-pyrano(2,3-c)pyridin-6-yl)methyl)amino)-1-piperidinyl)methyl)-1,2-dihydro-, (2r)-

Cas Number

1075236-89-3

Unique Ingredient Identifier (UNII)

DVF0PR037D

About Gepotidacin

Gepotidacin has been used in trials studying the treatment of Gonorrhea, Infections, Bacterial, and Infections, Respiratory Tract.

Gepotidacin Manufacturers

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

Gepotidacin Suppliers

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

Gepotidacin GMP

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

Gepotidacin CoA

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

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

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