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Chemistry

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Also known as: Ws-12, Ws 12, (1r,2s,5r)-n-(4-methoxyphenyl)-5-methyl-2-(propan-2-yl)cyclohexane-1-carboxamide, Fema no. 4681, N-(4-methoxyphenyl)-p-menthanecarboxamide, Cyclohexanecarboxamide, n-(4-methoxyphenyl)-5-methyl-2-(1-methylethyl)-, (1r,2s,5r)-
Molecular Formula
C18H27NO2
Molecular Weight
289.4  g/mol
InChI Key
HNSGVPAAXJJOPQ-XOKHGSTOSA-N
FDA UNII
1L7BVT4Z4Z

Acoltremon
Acoltremon is under investigation in clinical trial NCT05493111 (A Long-term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512).
1 2D Structure

Acoltremon

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(1R,2S,5R)-N-(4-methoxyphenyl)-5-methyl-2-propan-2-ylcyclohexane-1-carboxamide
2.1.2 InChI
InChI=1S/C18H27NO2/c1-12(2)16-10-5-13(3)11-17(16)18(20)19-14-6-8-15(21-4)9-7-14/h6-9,12-13,16-17H,5,10-11H2,1-4H3,(H,19,20)/t13-,16+,17-/m1/s1
2.1.3 InChI Key
HNSGVPAAXJJOPQ-XOKHGSTOSA-N
2.2 Other Identifiers
2.2.1 UNII
1L7BVT4Z4Z
2.3 Synonyms
2.3.1 MeSH Synonyms

1. N-(4-methoxyphenyl)-4-menthone-3-carboxamide

2. N-(4-methoxyphenyl)-p-menthone-3-carboxamide

3. Ws 12 Compound

4. Ws-12

5. Ws-12 Compound

6. Ws12 Compound

2.3.2 Depositor-Supplied Synonyms

1. Ws-12

2. Ws 12

3. (1r,2s,5r)-n-(4-methoxyphenyl)-5-methyl-2-(propan-2-yl)cyclohexane-1-carboxamide

4. Fema No. 4681

5. N-(4-methoxyphenyl)-p-menthanecarboxamide

6. Cyclohexanecarboxamide, N-(4-methoxyphenyl)-5-methyl-2-(1-methylethyl)-, (1r,2s,5r)-

7. (1r,2s,5r)-n-(4-methoxyphenyl)-5-methyl-2-(1-methylethyl)cyclohexanecarboxamide

8. N-(4-methoxyphenyl)-p-menthane-carboxamide

9. (1r,2s,5r)-methoxyphenyl)-5-methyl-2-propan-n-(4-2-ylcyclohexane-1-carboxamide

10. N-(4-methoxyphenyl)-5-methyl-2-(1-methylethyl)cyclohexanecarboxamide, (1r,2s,5r)-

11. 68489-09-8

12. Acoltremon

13. Cyclohexanecarboxamide,n-(4-methoxyphenyl)-5-methyl-2-(1-methylethyl)-, (1r,2s,5r)-

14. 1l7bvt4z4z

15. (1r,2s,5r)-n-(4-methoxyphenyl)-5-methyl-2-propan-2-ylcyclohexane-1-carboxamide

16. (1r,2s,5r)-2-isopropyl-n-(4-methoxyphenyl)-5-methylcyclohexane-1-carboxamide

17. Chembl2441929

18. Avx-012

19. [1r,2s,5r]-n-(4-methoxyphenyl)-p-menthanecarboxamide

20. Ws12

21. Hnsgvpaaxjjopq-xokhgstosa-n

22. Acoltremon [inn]

23. Unii-1l7bvt4z4z

24. Gtpl4343

25. Schembl2575067

26. Dtxsid10460636

27. Glxc-22261

28. Tca48909

29. Bdbm50442649

30. Akos024457397

31. Ws 12 Is Known As A Trpm8 Agonist.

32. Da-59157

33. Kxs

34. Hy-108449

35. Cs-0028711

36. E77039

37. Q27089230

38. N-(4-methoxyphenyl)-5-methyl-2- (1-methylethyl)cyclohexanecarboxamide, (1r,2s,5r)-

39. 847565-93-9

40. Cyclohexanecarboxamide, N-(4-methoxyphenyl)-5-methyl-2-(1-methylethyl)-, [1r-(1alpha,2beta,5alpha)]-

2.4 Create Date
2006-10-26
3 Chemical and Physical Properties
Molecular Weight 289.4 g/mol
Molecular Formula C18H27NO2
XLogP34.6
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count2
Rotatable Bond Count4
Exact Mass Da
Monoisotopic Mass Da
Topological Polar Surface Area38.3
Heavy Atom Count21
Formal Charge0
Complexity334
Isotope Atom Count0
Defined Atom Stereocenter Count3
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

API SUPPLIERS

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01

Neuland Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Maithri Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothMaithri Drugs: Dedicated to your API needs.

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Acoltremon

About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...

Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the pharmaceutical industry’s chemistry requirements, from the synthesis of library compounds to supplying NCEs and advanced intermediates at various stages in the clinical life cycle, as well as commercial launch. Neuland’s expertise is in the manufacturing of APIs and advanced intermediates from its USFDA-approved facilities. Its core competency lies in the application of powerful process chemistry to manufacturing in a regulatory-compliant environment.
Neuland

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Virtual BoothMaithri Drugs: Dedicated to your API needs.

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Acoltremon

About the Company : Maithri Drugs Pvt. Ltd. is a trusted global partner in Active Pharmaceutical Ingredients (APIs), supplying to pharmaceutical leaders in 60+ countries. With APIs spanning antivirals...

Maithri Drugs Pvt. Ltd. is a trusted global partner in Active Pharmaceutical Ingredients (APIs), supplying to pharmaceutical leaders in 60+ countries. With APIs spanning antivirals, antibiotics, ARVs, CNS, and cardiovascular segments, we deliver innovation with reliability. Our facilities are approved by US FDA, EDQM, Health Canada, and WHO-GMP, backed by numerous global DMFs and recognition as an Ecovadis-rated company. Supported by strong R&D, global patents, and customer-centric practices, Maithri ensures world-class APIs with regulatory excellence and exceptional service.
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Drugs in Development

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Details:

Tryptyr (acoltremon) is a TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease.


Lead Product(s): Acoltremon,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Tryptyr

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 28, 2025

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01

Alcon Inc

U.S.A
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BIO Partnering at JPM
Not Confirmed

Alcon Inc

U.S.A
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BIO Partnering at JPM
Not Confirmed

Details : Tryptyr (acoltremon) is a TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease.

Product Name : Tryptyr

Product Type : Miscellaneous

Upfront Cash : Inapplicable

May 28, 2025

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Details:

AR-15512 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dry Eye Syndromes.


Lead Product(s): Acoltremon,Polyvinyl Alcohol,Povidone

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 28, 2024

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02

Alcon Inc

U.S.A
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BIO Partnering at JPM
Not Confirmed

Alcon Inc

U.S.A
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BIO Partnering at JPM
Not Confirmed

Details : AR-15512 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dry Eye Syndromes.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 28, 2024

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Details:

AR-15512 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dry Eye Syndromes.


Lead Product(s): Acoltremon,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 09, 2024

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03

Alcon Inc

U.S.A
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BIO Partnering at JPM
Not Confirmed

Alcon Inc

U.S.A
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BIO Partnering at JPM
Not Confirmed

Details : AR-15512 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dry Eye Syndromes.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 09, 2024

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Details:

AR-15512 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dry Eye Syndromes.


Lead Product(s): Acoltremon,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 09, 2024

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04

Alcon Inc

U.S.A
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BIO Partnering at JPM
Not Confirmed

Alcon Inc

U.S.A
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BIO Partnering at JPM
Not Confirmed

Details : AR-15512 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dry Eye Syndromes.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 09, 2024

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Details:

AR-15512 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Dry Eye Syndromes.


Lead Product(s): Acoltremon,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 11, 2022

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05

Alcon Inc

U.S.A
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BIO Partnering at JPM
Not Confirmed

Alcon Inc

U.S.A
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BIO Partnering at JPM
Not Confirmed

Details : AR-15512 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Dry Eye Syndromes.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 11, 2022

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Details:

AR-15512 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dry Eye Syndromes.


Lead Product(s): Acoltremon,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 09, 2022

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06

Alcon Inc

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Alcon Inc

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Details : AR-15512 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dry Eye Syndromes.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 09, 2022

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Details:

AR-15512 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dry Eye Syndromes.


Lead Product(s): Acoltremon,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 04, 2022

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07

Alcon Inc

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Alcon Inc

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Details : AR-15512 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dry Eye Syndromes.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

May 04, 2022

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Details:

AR-15512 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dry Eye Syndromes.


Lead Product(s): Acoltremon,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 17, 2022

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08

Alcon Inc

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Alcon Inc

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Details : AR-15512 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dry Eye Syndromes.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

March 17, 2022

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Details:

Both formulations of AR-15512 were safe and well-tolerated. Ninety five percent of adverse events were mild with less than 3 percent of subjects discontinued due to adverse events.


Lead Product(s): Acoltremon,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 15, 2021

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09

Alcon Inc

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Alcon Inc

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Details : Both formulations of AR-15512 were safe and well-tolerated. Ninety five percent of adverse events were mild with less than 3 percent of subjects discontinued due to adverse events.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 15, 2021

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Details:

The COMET-1 trial is a randomized, double-masked, vehicle-controlled trial evaluating the efficacy and safety of AR-15512 (TRPM8 agonist) in patients with dry eye disease. AR-15512 is a TRPM8 agonist for the treatment of patients with dry eye disease.


Lead Product(s): Acoltremon,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 29, 2020

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10

Alcon Inc

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Alcon Inc

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Details : The COMET-1 trial is a randomized, double-masked, vehicle-controlled trial evaluating the efficacy and safety of AR-15512 (TRPM8 agonist) in patients with dry eye disease. AR-15512 is a TRPM8 agonist for the treatment of patients with dry eye disease.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 29, 2020

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FDF Dossiers

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Alcon Inc

U.S.A
Global ChemShow
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Alcon Inc

U.S.A
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Global ChemShow
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ACOLTREMON

Brand Name : TRYPTYR

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.003%

Packaging :

Approval Date : 2025-05-28

Application Number : 217370

Regulatory Info : RX

Registration Country : USA

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FDA Orange Book

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ACOLTREMON

Brand Name : TRYPTYR

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.003%

Approval Date : 2025-05-28

Application Number : 217370

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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DATA COMPILATION #PharmaFlow

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FDA approvals drop 24% in H1 2025; GSK’s UTI med, Vertex’s non-opioid painkiller lead pack of first-in-class meds
It has been a turbulent year for the US Food and Drug Administration (FDA), marked by reductions in both staff and budget, shake-ups at the top and a reduction in inspections. This upheaval has clearly impacted the functioning of the agency, with reports of missed deadlines and reduced responsiveness. This disruption resulted in a slowdown in new drug approvals in the first half of 2025 (H1 2025), as opposed to the same period last year. Incidentally, drug approvals in H1 2024 were also down by 19 percent compared to H1 2023. FDA’s Center for Drug Evaluation and Research (CDER) approved 16 novel drugs in H1 2025, down from 21 in H1 2024, a decline of nearly 24 percent. Of these, nine were small molecules and seven were biologics. The period saw eight first-in-class therapies get CDER’s approval, as opposed to 17 in H1 2024. FDA’s Center for Biologics Evaluation and Research (CBER) approved seven biologics in H1 2025, compared to eight in the same period last year. In comparison, both Health Canada and the European Medicines Agency (EMA) reported a strong rebound in approvals and authorizations, respectively. Health Canada approved 20 drugs in H1 2025, as opposed to 10 in H1 2024. Similarly, EMA authorized 19 new therapies in H1 2025, compared to 15 in H1 2024. Notably, EMA’s pending decisions increased to 25 in H1 2025, from 14 in the same period last year, while conditional authorizations remained static at five. This underscores EMA’s active regulatory pipeline, suggesting that more drugs could be approved in Europe soon.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available) Vertex’s non-opioid painkiller, GSK’s antibiotic for UTI, Merck’s RSV antibody bag FDA nods Oncology remained the single largest category in H1 2025 with seven new drugs being approved by the FDA, followed by four rare diseases and disorders and as many infections and infective diseases.  The eight drugs that were designated first-in-class in H1 2025 are: Journavx (Suzetrigine), Imaavy (nipocalimab), Emrelis (telisotuzumab vedotin), Blujepa (gepotidacin mesylate), Qfitlia (fitusiran), Avmapki Fakzynja Co-Pack (avutometinib potassium/defactinib hydrochloride), Tryptyr (acoltremon), and Andembry (garadacimab). In January, a new class of non-opioid pain therapy made a debut — FDA approved Vertex Pharmaceuticals’ Journavx (suzetrigine). This first-in-class oral analgesic could bring in US$ 2.9 billion in sales for Vertex by 2030. The half year also saw a new oral antibiotic — GSK’s Blujepa (gepotidacin) — for treating uncomplicated urinary tract infections (uUTIs) bag FDA approval. This is the first new antibiotic for uUTIs in nearly three decades. It treats infections caused by resistant pathogens such as E. coli and K. pneumoniae. In June, Merck’s Enflonsia (clesrovimab), a long-acting monoclonal antibody, won FDA approval to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants entering their first RSV season. A single 105 mg dose provides protection for about five months, the length of a typical RSV season. Enflonsia could bring in US$844 million in annual sales by 2030.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  FDA approves four meds for rare diseases, including SpringWorks’ Gomekli, Novartis’ Vanrafia In H1 2024, rare genetic diseases had witnessed some significant approvals. The trend continued in H1 2025. In February, Gomekli (mirdametinib), developed by SpringWorks Therapeutics, became the first approved therapy for neurofibromatosis type 1 (a genetic disorder that causes tumors to grow on nerve tissues) in adult and pediatric patients who have symptomatic plexiform neurofibromas (benign, complex nerve tumors) not amenable to complete resection. Analysts expect peak sales of around US$ 0.8 billion by 2030. Post this approval, SpringWorks got acquired by Merck KGaA for approximately US$ 3.9 billion. The same month, Ono Pharma-owned Deciphera’s Romvimza (vimseltinib) became the first oral therapy approved for another rare disease known as symptomatic tenosynovial giant cell tumor. This is a benign but aggressive growth that can be painful. This new drug offers patients an option beyond surgery. In March, Sanofi’s Qfitlia (fitusiran) was approved for routine prophylaxis in hemophilia A or B, with or without inhibitors. And in April, Novartis’ Vanrafia (atrasentan) was granted accelerated approval for IgA nephropathy (a chronic autoimmune kidney disease), which is at the risk of rapid progression. Vanrafia could bring in sales of over US$ 735 million by 2030. Johnson & Johnson secured approval for Imaavy (nipocalimab-aahu) for generalized myasthenia gravis (a chronic autoimmune disease that causes muscle weakness) in adults and adolescents. Imaavy’s sales could cross US$1.17 billion by 2030. Rare diseases continue to attract regulatory attention, with the trend carrying into the current quarter. July witnessed two noteworthy rare-disease approvals — Ekterly (garadacimab), CSL’s once-monthly prophylactic treatment for hereditary angioedema (a genetic disorder that causes recurrent episodes of swellings), and Sephience (pegvaliase-abcx), BioMarin’s new therapy for phenylketonuria (a rare metabolic disorder).   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  FDA greenlights new oncology therapies, including Astra’s Datroway, AbbVie’s Emrelis The field of oncology saw some notable new drug approvals. In January, Datroway (datopotamab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca and Daiichi Sankyo, was granted approval for adults with unresectable or metastatic, hormone receptor-positive, HER2-negative breast cancer. Later, in June, the FDA granted accelerated approval  to AstraZeneca;s Datroway for adults with locally advanced or metastatic, EGFR-mutated non-small cell lung cancer. The drug’s peak annual sales are projected at about US$ 4.2 billion by 2030. In May, Emrelis (telisotuzumab vedotin-tllv), AbbVie’s ADC was granted FDA’s accelerated approval. Emrelis treats locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) characterized by significantly increased levels of the c-Met protein in cancer cells. FDA also approved a companion diagnostic test — Roche's Ventana — in May to determine the c-Met protein biomarker status in order to identify patients eligible for Emrelis.  The same month, FDA also granted accelerated approval to Verastem’s Avmapki Fakzynja Co-pack, a dual oral therapy for adults with KRAS‑mutated recurrent low‑grade serous ovarian cancer (LGSOC). This novel regimen combines two inhibitors — avutometinib and defactinib — to disrupt critical signaling pathways that fuel tumor growth. In ophthalmology, Alcon re-entered the prescription pharmaceutical market with Tryptry (acoltremon), a first-in-class TRPM8 agonist for dry eye disease, which stimulates corneal nerves to increase tear production.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  Our view The changes in the FDA are clearly having a far-reaching impact on the global pharmaceutical industry. There have been reports of drugmakers losing confidence in the FDA, which has been a gold standard for drug regulation. Some American biotechs are shifting early trials outside of the US. With EMA and Health Canada authorizing/approving a larger number of drugs in H1 2025, we do see some changes underway that may eventually reshape drug development.  

Impressions: 6343

https://www.pharmacompass.com/radio-compass-blog/fda-approvals-drop-24-in-h1-2025-gsk-s-uti-med-vertex-s-non-opioid-painkiller-lead-pack-of-first-in-class-meds

#PharmaFlow by PHARMACOMPASS
28 Aug 2025

STOCK RECAP #PipelineProspector

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Patents & EXCLUSIVITIES

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US Patents

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ACOLTREMON

US Patent Number : 10028920

Drug Substance Claim :

Drug Product Claim :

Application Number : 217370

Patent Use Code : U-1900

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-09-08

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ACOLTREMON

US Patent Number : 9433679

Drug Substance Claim :

Drug Product Claim :

Application Number : 217370

Patent Use Code : U-1900

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-09-08

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ACOLTREMON

US Patent Number : 9095609

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 217370

Patent Use Code : U-1900

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-09-08

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ACOLTREMON

US Patent Number : 12336971

Drug Substance Claim :

Drug Product Claim :

Application Number : 217370

Patent Use Code : U-1900

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2042-12-16

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Global ChemShow
Not Confirmed

ACOLTREMON

US Patent Number : 11850221

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 217370

Patent Use Code : U-1900

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2042-12-16

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Looking for 68489-09-8 / Acoltremon API manufacturers, exporters & distributors?

Acoltremon manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Acoltremon

Synonyms

Ws-12, Ws 12, (1r,2s,5r)-n-(4-methoxyphenyl)-5-methyl-2-(propan-2-yl)cyclohexane-1-carboxamide, Fema no. 4681, N-(4-methoxyphenyl)-p-menthanecarboxamide, Cyclohexanecarboxamide, n-(4-methoxyphenyl)-5-methyl-2-(1-methylethyl)-, (1r,2s,5r)-

Cas Number

68489-09-8

Unique Ingredient Identifier (UNII)

1L7BVT4Z4Z

About Acoltremon

Acoltremon is under investigation in clinical trial NCT05493111 (A Long-term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512).

Acoltremon Manufacturers

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

Acoltremon Suppliers

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

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

Acoltremon GMP

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

Acoltremon CoA

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

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

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