Drugs / Aceclidine
Aceclidine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | VIZZ | — | 2025-07-31 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06270030 | Mar → Apr 2024 | presbyopia | Corxel Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05936489 | Jul → Oct 2023 | presbyopia | LENZ Therapeutics, Inc | Completed | No outcome recorded |
| Phase 22 trials · 2 met primary | ||||||
| Phase 2 | NCT05431543 | Aug → Dec 2022 | presbyopia | LENZ Therapeutics, Inc | Completed | Met primary |
| Phase 2 | NCT05294328 | May → Aug 2022 | presbyopia | LENZ Therapeutics, Inc | Completed | Met primary |
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT06045299 | Sep 2023 → Aug 2024 | presbyopia | Corxel Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT05728944 | Mar → Dec 2023 | presbyopia | LENZ Therapeutics, Inc | Completed | Met primary |
| Phase 3 | NCT05753189 | Feb 2023 → Feb 2024 | presbyopia | LENZ Therapeutics, Inc | Completed | No outcome recorded |
| Phase 3 | NCT05656027 | Dec 2022 → Dec 2023 | presbyopia | LENZ Therapeutics, Inc | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT03201562 Comparator | Apr 2017 → May 2018 | presbyopia | LENZ Therapeutics, Inc | Completed | Met primary |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-04-20 | LENZ Therapeutics, Inc | Regulatory LENZ Therapeutics Announces Submission of Marketing Authorization Application to the Medicines and Healthcare products Regulatory Agency for VIZZ® for the Treatment of Presbyopia in the United Kingdom lenz-tx.com ↗ |
| 2026-03-10 | LENZ Therapeutics, Inc | Regulatory LENZ Therapeutics Announces Submission of Marketing Authorization Application to European Medicines Agency for VIZZ® for the Treatment of Presbyopia lenz-tx.com ↗
LENZ Therapeutics, Inc. (Nasdaq: LENZ) today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the review and approval of VIZZ ® (aceclidine ophthalmic solution) 1.44%, the first and only aceclidine-based eye drop for the treatment of presbyopia in adults. |
| 2025-12-01 | LENZ Therapeutics, Inc | Regulatory LENZ Therapeutics Announces MFDS Submission of New Drug Application for LNZ100 (VIZZ™) in South Korea for the Treatment of Presbyopia lenz-tx.com ↗
Submission of NDA in South Korea by Lotus Pharmaceutical results in the second ex-U.S. regulatory submission for VIZZ |
| 2025-07-31 | LENZ Therapeutics, Inc | Regulatory LENZ Therapeutics Announces US FDA Approval of VIZZ™ for the Treatment of Presbyopia lenz-tx.com ↗
LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), today announced the US Food and Drug Administration (“FDA”) approved VIZZ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults. |
| 2025-07-28 | LENZ Therapeutics, Inc | Regulatory LENZ Therapeutics Announces NMPA Submission of New Drug Application for LNZ100 in China for the Treatment of Presbyopia lenz-tx.com ↗
today announced that CORXEL Pharmaceuticals (“CORXEL”) has submitted the New Drug Application (NDA) for LNZ100 to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People’s Republic of China (PRC). |
| 2024-10-27 | LENZ Therapeutics, Inc | Results CORXEL and LENZ Therapeutics Announce Positive Topline Data from China Phase 3 Presbyopia Trial of LNZ100 lenz-tx.com ↗
Primary endpoint was met with 74% of participants dosed with LNZ100 achieving three-lines or greater improvement at 3 hours post treatment，and maintaining their optimal distance visual acuity (i.e., not losing 5 or more letters). |
| 2024-10-21 | LENZ Therapeutics, Inc | Regulatory LENZ Therapeutics Announces FDA Acceptance of New Drug Application for LNZ100 for the Treatment of Presbyopia lenz-tx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for LNZ100 for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. |
| 2024-08-12 | LENZ Therapeutics, Inc | Regulatory LENZ Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for LNZ100 for the Treatment of Presbyopia lenz-tx.com ↗
“The submission of our NDA for LNZ100 is a significant milestone for LENZ and is a testament to the tremendous focus, execution and collaboration of our team,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. |
| 2024-04-03 | LENZ Therapeutics, Inc | Results LENZ Therapeutics Announces Positive Topline Data from Phase 3 CLARITY Presbyopia Trials lenz-tx.com ↗
LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing the first aceclidine-based eye drop to improve near vision in people with presbyopia, today announced positive topline results from its Phase 3 CLARITY study of two investigational formulations of aceclidine, LNZ100 and LNZ101, for the treatment of presbyopia, the inevitable loss of near vision that impacts the daily lives of nearly all people over 45. |
| 2022-10-18 | LENZ Therapeutics, Inc | Results LENZ Therapeutics Announces Positive Topline Data from Phase 2 INSIGHT Trial of LNZ100 and LNZ101 to Treat Presbyopia lenz-tx.com ↗
Both LNZ100 and LNZ101 maintained statistical significance of three-line or greater improvement compared to vehicle for all timepoints including the last measured at 10 hours, 37% and 48% respectively. |
All press releases naming this drug 16 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Aceclidine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05294328 ↗ |
| Known as | 3-quinuclidinol acetate (ester) | ChEMBL registry synonym — accepted as the source's own label CHEMBL20835 ↗ |
| Known as | 3-quinuclidinol dl-form acetate (ester) | ChEMBL registry synonym — accepted as the source's own label CHEMBL20835 ↗ |
| Known as | Aceclidina | ChEMBL registry synonym — accepted as the source's own label CHEMBL20835 ↗ |
| Known as | Aceclidine hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL20835 ↗ |
| Known as | Aceclidine hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL20835 ↗ |
| Known as | LNZ100 | “LNZ100 (Aceclidine) non-preserved ophthalmic solution” NCT05936489 ↗1“LNZ100- aceclidine ophthalmic solution” NCT05294328 ↗ |
| Known as | NSC-657843 | ChEMBL registry synonym — accepted as the source's own label CHEMBL20835 ↗ |
| Known as | NSC-758239 | ChEMBL registry synonym — accepted as the source's own label CHEMBL20835 ↗ |
| Modality | Small molecule | — CHEMBL20835 ↗ |
| Route | Other | “Aceclidine ophthalmic solution” NCT05294328 ↗ |