Drugs / Alcaftadine
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LASTACAFT | — | 2021-12-10 | fda.gov ↗ |
| Approved | US (FDA) | LASTACAFT | — | 2010-07-28 | fda.gov ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 35 trials · 1 met primary | ||||||
| Phase 3 | NCT00889330 | Apr → May 2009 | conjunctivitis | Vistakon Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00364091 | Aug → Oct 2006 | conjunctivitis | Vistakon Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00241319 | Oct → Dec 2005 | conjunctivitis | Vistakon Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00244543 | Oct → Nov 2005 | conjunctivitis | Vistakon Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00223951 | Sep → Dec 2005 | — | Vistakon Pharmaceuticals | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01808768 | Apr → Oct 2013 | allergic rhinitis, conjunctivitis | Starx Research Center, LLC | Unknown | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 4 | NCT02308501 Comparator | Dec 2014 → Feb 2015 | conjunctivitis | ORA, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01732757 Comparator | Nov → Dec 2012 | atopic conjunctivitis | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01470118 Comparator | Oct → Dec 2011 | atopic conjunctivitis | Allergan | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-10-01 | Alembic Pharmaceuticals Ltd. | Regulatory 3rd October, 2024, 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) Alcaftadine Ophthalmic Solution, 0.25% (OTC). |
| 2020-04-01 | Alembic Pharmaceuticals Ltd. | Regulatory 20th April, 2020, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals announces USFDA Tentative Approval for Alcaftadine Ophthalmic Solution, 0.25%. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-10-01 | Alembic Pharmaceuticals Ltd. | 3rd October, 2024, Vadodara, India alembicpharmaceuticals.com ↗ |
| 2022-03-15 | AbbVie | Now Available Over the Counter, LASTACAFT® Provides Eye Allergy Itch Relief in Minutes that Lasts Through 16 Hours abbvie.com ↗ |
| 2020-04-01 | Alembic Pharmaceuticals Ltd. | 20th April, 2020, Vadodara, India alembicpharmaceuticals.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | alcaftadine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00889330 ↗ |
| Known as | Alcaftadina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201747 ↗ |
| Known as | Lastacaft | “Alcaftadine(Lastacaft™)” NCT01808768 ↗ |
| Known as | R89674 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00244543 ↗ |
| Action | Inhibit | “Histamine H1 receptor antagonist” CHEMBL1201747 ↗ |
| Modality | Small molecule | — CHEMBL1201747 ↗ |
| Target | HRH1 | “Histamine H1 receptor antagonist” CHEMBL1201747 ↗ |