Drugs / Pilocarpine
Pilocarpine
also known as
pilocarpine HCl · pilocarpine hydrochloride · NV701 · Pilocarpine HCl Ophthalmic Solution · Qlosi · Salagen
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | VUITY | — | 2023-03-28 | fda.gov ↗ |
| Label expansion | US (FDA) | SALAGEN | — | 1998-02-11 | fda.gov ↗ |
| Approved | US (FDA) | OCUSERT PILO-20 | — | 1974-07-29 | fda.gov ↗ |
Trials 32 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05564832 | Aug → Dec 2022 | — | Shahid Beheshti University of Medical Sciences | Unknown | No outcome recorded |
| Phase 0 | NCT03825081 | Jan → Sep 2019 | presbyopia | Massachusetts Eye and Ear Infirmary | Unknown | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT05006911 | Aug → Sep 2021 | presbyopia | Optall Vision | Unknown | No outcome recorded |
| Phase 1 | NCT05006898 | Jun → Jul 2020 | presbyopia | Optall Vision | Completed | No outcome recorded |
| Phase 1 | NCT02447315 | May → Jun 2015 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05119920 | Jan → Jul 2022 | dry eye syndrome | Glaukos Corporation | Completed | No outcome recorded |
| Phase 2 | NCT05124275 | Jan → Sep 2022 | presbyopia | Glaukos Corporation | Completed | No outcome recorded |
| Phase 2 | NCT04675151 | Feb → May 2021 | presbyopia | Ocuphire Pharma, Inc. | Completed | No outcome recorded |
| Phase 316 trials | ||||||
| Phase 3 | NCT06451666 | Jun 2024 → Nov 2025 | presbyopia | CSPC Ouyi Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT05506137 | Jan 2023 → Feb 2025 | — | Maastricht University Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT05646719 | Dec 2022 → Oct 2023 | presbyopia | Ocuphire Pharma, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05578001 | Jul → Dec 2022 | cataract, presbyopia | Isfahan University of Medical Sciences | Unknown | No outcome recorded |
| Phase 3 | NCT05114486 | Nov 2021 → Sep 2022 | presbyopia | Eyenovia Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04983589 | Sep 2021 → Feb 2022 | presbyopia | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT04657172 | Dec 2020 → Mar 2021 | presbyopia | Eyenovia Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04005079 | Jun 2019 → Jan 2021 | ocular hypertension, open-angle glaucoma | Montefiore Medical Center | Withdrawn | No outcome recorded |
| Phase 3 | NCT03933631 | May 2019 → Jun 2028 expected | glaucoma | Montefiore Medical Center | Recruiting | No outcome recorded |
| Phase 3 | NCT03857542 | Mar 2019 → Sep 2020 | presbyopia | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT03804268 | Dec 2018 → Oct 2019 | presbyopia | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT02485067 | Jan 2015 → Jul 2016 | overactive bladder | SK Chemicals Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00343382 | Dec 2006 → Jul 2009 | breast cancer, vaginal disorder | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 3 | NCT04470479 | Mar 2005 → Apr 2006 | dry eye syndrome | Federal University of São Paulo | Completed | No outcome recorded |
| Phase 3 | NCT00168181 | Apr 2002 → Apr 2008 | head and neck cancer | Alberta Health services | Completed | No outcome recorded |
| Phase 3 | NCT00003139 | Mar 1998 → Jan 2001 | head and neck cancer, mouth disorder | Radiation Therapy Oncology Group | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07113210 | Jul → Oct 2025 overdue | dry eye syndrome, presbyopia | Southern College of Optometry | Recruiting | No outcome recorded |
| Phase 4 | NCT05238233 | Apr 2022 → Jan 2023 | anisocoria | Prisma Health-Upstate | Completed | No outcome recorded |
| Phase 4 | NCT02982577 | Apr 2016 → Jun 2017 | — | University of Sao Paulo | Unknown | No outcome recorded |
| Phase 4 | NCT00803803 | Aug 1978 → Aug 1979 | open-angle glaucoma | Wills Eye | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07012512 | Jun → Dec 2025 overdue | eye accommodation disease | Mansoura University | Not yet recruiting | No outcome recorded |
| — | NCT05352854 | May → Jun 2022 | glaucoma, myopia | Yune Zhao | Unknown | No outcome recorded |
| — | NCT02754570 | Jul 2016 → Dec 2017 | ocular hypertension, open-angle glaucoma | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT01627626 | Aug → Oct 2011 | — | Jeong-seong Kwon | Completed | No outcome recorded |
Also used as a comparator or background therapy in 16 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT06783686 Comparator | Jan → Apr 2025 | congenital microcoria | Novus Vision LLC | Completed | No outcome recorded |
| Phase 0 | NCT04195100 Comparator | Apr → Dec 2019 | — | Maastricht University Medical Center | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT05001243 Comparator | Aug 2021 | presbyopia | Optall Vision | Unknown | No outcome recorded |
| Phase 1 | NCT02420782 Background | May 2015 → May 2016 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01036035 Comparator | Sep 2009 → Mar 2010 | — | TheraVida, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00656513 Comparator | Sep 2008 → Nov 2014 | head and neck cancer | Radiation Therapy Oncology Group | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00003686 Comparator | May 1998 → Nov 2007 | mouth disorder | NCIC Clinical Trials Group | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00762645 Comparator | Feb 2007 → May 2008 | angle-closure glaucoma | Alcon Research | Completed | No outcome recorded |
| Phase not applicable8 trials | ||||||
| — | NCT06752278 Comparator | Oct → Dec 2024 | dry eye syndrome | Al-Azhar University | Completed | No outcome recorded |
| — | NCT03460964 Background | May 2018 → Sep 2019 | diabetes mellitus | University of California, San Diego | Terminated | No outcome recorded |
| — | NCT02935894 Background | Nov 2016 → Jun 2017 | — | USDA, Western Human Nutrition Research Center | Completed | No outcome recorded |
| — | NCT02865473 Background | Apr 2016 → Dec 2023 | glaucoma | Medical University of Vienna | Unknown | No outcome recorded |
| — | NCT02613013 Background | Oct 2015 → Mar 2020 | primary angle-closure glaucoma | Sun Yat-sen University | Unknown | No outcome recorded |
| — | NCT02310789 Background | Jul 2015 → Aug 2016 | cystic fibrosis | Richard Barry Moss | Completed | No outcome recorded |
| — | NCT01690052 Comparator | Jan 2009 → Jun 2010 | — | University of Kentucky | Completed | No outcome recorded |
| — | NCT00804115 Comparator | Aug 2000 → Sep 2007 | exfoliation syndrome, ocular hypertension | The New York Eye & Ear Infirmary | Unknown | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-04-05 | AbbVie | Allergan, an AbbVie Company, Announces Positive Topline Phase 3 Results Evaluating Investigational Twice-Daily Administration of VUITY™ (pilocarpine HCI ophthalmic solution) 1.25% in Adults with Age-Related Blurry Near Vision (Presbyopia) abbvie.com ↗ |
| 2021-12-09 | AbbVie | VUITY™ (pilocarpine HCI ophthalmic solution) 1.25%, the First and Only FDA-Approved Eye Drop to Treat Age-Related Blurry Near Vision (Presbyopia), is Now Available abbvie.com ↗ |
| 2021-10-29 | AbbVie | U.S. Food and Drug Administration Approves VUITY™ (pilocarpine HCI ophthalmic solution) 1.25%, the First and Only Eye Drop to Treat Presbyopia (Age-Related Blurry Near Vision) abbvie.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 49 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pilocarpine | “2% pilocarpine in the postoperative period in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)” NCT04005079 ↗46“Combination of Tolterodine 2mg and Pilocarpine 9mg” NCT02485067 ↗ “Pilocarpine was instilled in the other oye.” NCT05006898 ↗ “Oral Pilocarpine (Salagen)” NCT00168181 ↗ |
| Known as | NV701 | “1 drop of NV701 (1.25% pilocarpine)” NCT06783686 ↗ |
| Known as | pilocarpine HCl | “PURPOSE: To evaluate the efficacy of topical pilocarpine HCl 1.25% (Pilo) in treating presbyopia in individuals with or without a history of laser vision correction...” PMID 37702453 ↗ Jan 20243“Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days” NCT06451666 ↗ “Qlosi™ (pilocarpine HCL ophthalmic solution)” NCT07113210 ↗ |
| Known as | Pilocarpine HCl Ophthalmic Solution | “Pilocarpine HCl Ophthalmic Solution (AGN-190584)” NCT03857542 ↗ |
| Known as | pilocarpine hydrochloride | “A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride (HCl) ophthalmic solution (AGN-190584) when administered bilaterally, once daily for...” NCT03804268 ↗3“5mg pilocarpine hydrochloride tablets” NCT00003139 ↗ “Drug: pilocarpine hydrochloride” NCT00003686 ↗ “Drug: Pilocarpine Hydrochloride” NCT04470479 ↗ |
| Known as | Qlosi | “Qlosi™ (pilocarpine HCL ophthalmic solution)” NCT07113210 ↗ |
| Known as | Salagen | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00168181 ↗ |
| Action | Activate | “THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic agonist (pilocarpine).” NCT01036035 ↗ |
| Route | Oral | “Oral pilocarpine or placebo is administered” NCT00003139 ↗ |