Drugs / Arformoterol
Arformoterol
also known as
Arformoterol tartrate · Brovana · ARFORMOTEROL FUMARATE · Brovana, (R,R)-formoterol · Formoterol r,r-form · Formoterol r,r-form l-tartrate · RR formoterol
Small molecule targets ADRB2 via activation
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | BROVANA | — | 2014-02-27 | fda.gov ↗ |
| Approved | US (FDA) | BROVANA | — | 2006-10-06 | fda.gov ↗ |
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials | ||||||
| Phase 2 | NCT05055414 | Nov 2021 → Oct 2022 | COVID-19 | Korea United Pharm. Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT00583947 | Jan → Dec 2008 | asthma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00685529 | Apr → Oct 2005 | chronic obstructive pulmonary disease | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00691405 | Oct 2003 → May 2004 | chronic obstructive pulmonary disease | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 36 trials · 1 met primary | ||||||
| Phase 3 | NCT00909779 | Jun 2009 → Jun 2012 | chronic obstructive pulmonary disease | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase 3 | NCT00662779 | Apr 2008 → Mar 2009 | exercise-induced bronchoconstriction | University of New Mexico | Withdrawn | No outcome recorded |
| Phase 3 | NCT00250679 | Oct 2005 → Oct 2007 | bronchitis, pulmonary emphysema | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00064415 | Jun 2002 → Dec 2004 | chronic bronchitis, pulmonary emphysema | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00064402 | Apr 2002 → Mar 2004 | chronic bronchitis, pulmonary emphysema | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00685841 | Feb 2002 → Jun 2003 | chronic obstructive pulmonary disease | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 46 trials · 1 met primary | ||||||
| Phase 4 | NCT03219866 | Oct 2017 → Apr 2020 | chronic obstructive pulmonary disease | Wake Forest University Health Sciences | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02275481 | Nov 2014 → Sep 2016 | chronic obstructive pulmonary disease | Sumitomo Pharma America, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01361984 | Jun 2011 → Jun 2013 | chronic bronchitis, pulmonary emphysema | University of California, Los Angeles | Unknown | No outcome recorded |
| Phase 4 | NCT00819637 | Jan → Nov 2009 | acute asthma | Henry Ford Health System | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00773786 | Oct 2008 → May 2009 | chronic obstructive pulmonary disease | Trinity Health Of New England | Completed | No outcome recorded |
| Phase 4 | NCT00571428 | Nov 2007 → Mar 2008 | chronic obstructive pulmonary disease | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase not applicable1 trial · 1 missed | ||||||
| — | NCT01391559 | Jul 2011 → Oct 2012 | chronic obstructive pulmonary disease | Dartmouth-Hitchcock Medical Center | Completed | Missed primary |
| Comparator or background therapy3 trials | ||||||
| Phase 4 | NCT00754546 Comparator | Aug 2008 → May 2009 | chronic obstructive pulmonary disease | Dartmouth-Hitchcock Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00424528 Comparator | Dec 2006 → Oct 2007 | bronchitis, pulmonary emphysema | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| — | NCT00846287 Comparator | Nov 2008 → Apr 2011 | chronic obstructive pulmonary disease | University of Massachusetts, Worcester | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2022-05-01 | Alembic Pharmaceuticals Ltd. | Regulatory 111h May, 2022, Vadodara, India , alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 ml Unit-dose Vial. |
| 2022-02-08 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Arformoterol Tartrate Inhalation Solution15 mcg (base)/2 ml lupin.com ↗ |
| 2021-06-23 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials glenmarkpharma.com ↗
Glenmark Pharmaceuticals receives ANDA approval for Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials |
| 2020-04-29 | Lupin Limited | Regulatory Lupin Receives Tentative Approval for Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 mL lupin.com ↗
Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced that it has received tentative approval for its Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 mL, Unit-dose Vials, from the United States Food and Drug Administration (U.S. FDA) to market a generic version of Brovana® Inhalation Solution, 15 mcg/2 mL of Sunovion Pharmaceuticals Inc. (Sunovion). |
All press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-10-20 | Sumitomo Pharma America, Inc. | Sumitomo Pharma Announces Intent to Divest Brovana and Xopenex HFA to Lupin sumitomo-pharma.com ↗ |
| 2022-05-01 | Alembic Pharmaceuticals Ltd. | 111h May, 2022, Vadodara, India , alembicpharmaceuticals.com ↗ |
| 2022-02-08 | Lupin Limited | Lupin Receives Approval from U.S. FDA for Arformoterol Tartrate Inhalation Solution15 mcg (base)/2 ml lupin.com ↗ |
| 2021-06-23 | Glenmark Pharmaceuticals Ltd. India | Glenmark Pharmaceuticals receives ANDA approval for Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials glenmarkpharma.com ↗ |
| 2021-06-02 | Lupin Limited | Lupin Launches Authorized Generic Version of Brovana® in the United States lupin.com ↗ |
| 2020-04-29 | Lupin Limited | Lupin Receives Tentative Approval for Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 mL lupin.com ↗ |
| 2012-05-25 | Sumitomo Pharma America, Inc. | Sunovion Pharmaceuticals settles dispute on BROVANA patent litigation sumitomo-pharma.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Arformoterol | “Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days” NCT05055414 ↗18“Subjects will receive the drug arformoterol prior to scanning” NCT00846287 ↗ |
| Known as | ARFORMOTEROL FUMARATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1363 ↗ |
| Known as | Arformoterol tartrate | “Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer...” NCT02275481 ↗6“Arformoterol tartrate 15 µg/2ml (Brovana) nebulized via PARI-LC Plus® nebulizer with a mouthpiece, connected to a PRONEB® Ultra compressor.” NCT01361984 ↗ “Arformoterol tartrate (arformoterol, 15 μg bid) is a nebulized long-acting β2-agonist approved for maintenance treatment of COPD.” PMID 25451347 ↗ Dec 2014 “Arformoterol tartrate inhalation solution 15 mcg twice daily and placebo inhalation powder once daily.” NCT00424528 ↗ “Arformoterol tartrate inhalation solution” NCT00250679 ↗ “Arformoterol Tartrate Inhalation Solution” NCT00571428 ↗ “Arformoterol tartrate inhalation solution” NCT00691405 ↗ |
| Known as | Brovana | “Arformoterol (Brovana)” NCT00773786 ↗ |
| Known as | Brovana, (R,R)-formoterol | “Brovana, (R,R)-formoterol” NCT00685529 ↗ |
| Known as | Formoterol r,r-form | ChEMBL registry synonym — accepted as the source's own label CHEMBL1363 ↗ |
| Known as | Formoterol r,r-form l-tartrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1363 ↗ |
| Known as | RR formoterol | “arformoterol (RR formoterol)” NCT00819637 ↗ |
| Action | Activate | “Beta-2 adrenergic receptor agonist” CHEMBL1363 ↗ |
| Modality | Small molecule | — CHEMBL1363 ↗ |
| Route | Inhaled | “arformoterol tartrate inhalation solution” NCT00064402 ↗ |
| Target | ADRB2 | “Beta-2 adrenergic receptor agonist” CHEMBL1363 ↗ |