Drugs / Pilocarpine
Pilocarpine
also known as
pilocarpine HCl · pilocarpine hydrochloride · NV701 · Pilocarpine HCl Ophthalmic Solution · Qlosi · Salagen
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed presbyopia 1 milestone | |||||
| Filed | Other | BESKA | presbyopia | 2026-07-15 | “Aspen has submitted a New Drug Application in Australia to the Therapeutic Goods Administration (TGA) for the review and approval of BESKA” orasis-pharma.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| Phase 316 trials · 4 met primary · 1 missed | ||||||
| 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 | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT03804268 | Dec 2018 → Oct 2019 | presbyopia | Allergan | Completed | Met primary |
| 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 | Missed primary |
| 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 |
| Comparator or background therapy16 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 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 2/3 | NCT00656513 Comparator | Sep 2008 → Nov 2014 | head and neck cancer | Radiation Therapy Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00003686 Comparator | May 1998 → Nov 2007 | mouth disorder | NCIC Clinical Trials Group | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00762645 Comparator | Feb 2007 → May 2008 | angle-closure glaucoma | Alcon Research | Completed | No outcome recorded |
| — | 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 |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-07-15 | Orasis Pharmaceuticals Ltd. | Regulatory Orasis Pharmaceuticals Announces Australia Submission of a New Drug Application for BESKA for the Treatment of Presbyopia orasis-pharma.com ↗
Submission of New Drug Application (NDA) in Australia by Aspen Pharmacare Australia (Aspen Australia) marks the first ex-U.S. regulatory submission (known as QLOSI® in the U.S.) |
| 2026-01-27 | Orasis Pharmaceuticals Ltd. | Results New Data Demonstrate Qlosi™ Is Pupil Selective With Ciliary Muscle Movement No Different Than A Balanced Salt Solution (BSS) Control orasis-pharma.com ↗
Orasis Pharmaceuticals, an ophthalmic pharmaceutical company delivering solutions to reshape vision possibilities, announced data supporting Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4% is pupil selective, significantly reducing pupil diameter without a statistically significant change in ciliary muscle response in presbyopic eyes. |
| 2023-10-17 | Orasis Pharmaceuticals Ltd. | Regulatory Orasis Pharmaceuticals Announces FDA Approval of QLOSI™ (pilocarpine hydrochloride ophthalmic solution) 0.4% for the Treatment of Presbyopia orasis-pharma.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved QLOSI™ (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults. |
| 2023-01-10 | Glaukos Corporation | Results Glaukos Announces Positive Clinical Updates for Several Corneal Health Pipeline Programs glaukos.com ↗
Promising Phase 2a Results for GLK-301 (iLution – Dry Eye Disease) Support Planned Phase 2b Study to Commence in 2023 |
| 2022-10-24 | Ocuphire Pharma, Inc. | Results Ocuphire Announces Six Poster Presentations on Nyxol and APX3330 at the American Academy of Optometry Annual Meeting opusgtx.com ↗
Phentolamine Alone and in Combination with Low Dose Pilocarpine Improves Near Vision in Presbyopic Subjects in the VEGA-1 Phase 2 Trial |
| 2022-04-29 | AbbVie | Results AbbVie Reports First-Quarter 2022 Financial Results abbvie.com ↗
AbbVie announced positive results from the Phase 3 VIRGO trial evaluating the safety and efficacy of investigational twice-daily administration of Vuity (pilocarpine HCl ophthalmic solution) 1.25% in adults with age-related blurry near vision (presbyopia). |
| 2022-04-05 | AbbVie | Results 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 ↗
In the VIRGO trial evaluating twice-daily administration of VUITY, the primary endpoint of improving near vision without compromising distance vision at Day 14, Hour 9 was met |
| 2021-10-29 | AbbVie | Regulatory 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 ↗
Allergan, an AbbVie (NYSE: ABBV) company, today announced the U.S. Food and Drug Administration (FDA) approval of VUITY ™ (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. |
| 2021-08-12 | Ocuphire Pharma, Inc. | Results Ocuphire Announces Financial Results for the Second Quarter 2021 and Provides Corporate Update opusgtx.com ↗
Nyxol plus Low-Dose Pilocarpine Phase 2 Trial Results Show Potential for Best-in-Class Presbyopia Drug Profile in Data Presentations at 2021 ASCRS Meeting |
| 2021-07-25 | AbbVie | Results New Data Presented on the Safety and Efficacy of Investigational AGN-190584 as a Potential Novel Treatment for Presbyopia, a Common and Progressive Eye Condition abbvie.com ↗
Allergan, an AbbVie (NYSE: ABBV) company, today announced new data, including the full results from the Phase 3 GEMINI 1 clinical study, evaluating the efficacy, safety and tolerability of investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. |
| 2021-06-30 | Ocuphire Pharma, Inc. | Results Ocuphire’s VEGA-1 Phase 2 Trial in Presbyopia Meets Primary and Secondary Endpoints opusgtx.com ↗
Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, today announced that the VEGA-1 Phase 2 clinical trial evaluating the efficacy and safety of Nyxol in combination with low-dose pilocarpine (LDP) in presbyopic subjects successfully met its primary and many secondary endpoints. |
| 2021-02-25 | AbbVie | Regulatory Allergan, an AbbVie Company, Submits New Drug Application for Investigational AGN-190584 for the Treatment of Presbyopia abbvie.com ↗
Allergan, an AbbVie (NYSE: ABBV) company, today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. |
| 2020-10-28 | AbbVie | Results Allergan, an AbbVie Company, Announces Positive Phase 3 Topline Results for Investigational AGN-190584 for the Treatment of Presbyopia abbvie.com ↗
Allergan, an AbbVie (NYSE: ABBV) company, today announced the Phase 3 GEMINI 1 and 2 clinical trials evaluating the efficacy, safety and tolerability of investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of symptoms associated with presbyopia, met their primary efficacy endpoint. |
| 2006-04-05 | Impax Laboratories, LLC | Regulatory IMPAX Receives FDA Approval for Generic Version of SALAGEN(R) Tablets; Global Pharmaceuticals Division to Launch amneal.com ↗
IMPAX Laboratories, Inc. (NASDAQ:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of SALAGEN(R) (Pilocarpine Hydrochlorine) 5 and 7.5 mg Tablets. |
All press releases naming this drug 21 releases
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 ↗ |