Drugs / N-Acetylcysteine Amide
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05994534 | Oct 2023 → Aug 2026 overdue | cystinosis | Nacuity Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07290530 | Dec 2026 → Jul 2029 expected | Usher syndrome, retinitis pigmentosa | Nacuity Pharmaceuticals, Inc. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-10-02 | Nacuity Pharmaceuticals, Inc. | Regulatory Nacuity Pharmaceuticals Granted U.S. FDA Breakthrough Therapy Designation for NPI-001 (N-acetylcysteine amide) Tablets for the Treatment of Retinitis Pigmentosa nacuity.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to NPI-001 (N-acetylcysteine amide) tablets |
| 2025-01-21 | Nacuity Pharmaceuticals, Inc. | Regulatory Nacuity Pharmaceuticals Granted U.S. FDA Fast Track Designation for NPI-001 (N-acetylcysteine amide) Tablets for the Treatment of Retinitis Pigmentosa nacuity.com ↗
Nacuity Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing treatments for retinitis pigmentosa, cataracts and other diseases caused by oxidative stress, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NPI-001 (N-acetylcysteine amide) tablets, Nacuity’s proprietary investigational therapy for the treatment of patients with retinitis pigmentosa (RP). |
| 2024-03-12 | Nacuity Pharmaceuticals, Inc. | Regulatory Arctic Therapeutics and Nacuity Pharmaceuticals Announce European Medicines Agency Approval to Initiate First Clinical Trial of AT-001 (NPI-001) for the Treatment of HCCAA nacuity.com ↗ |
All press releases naming this drug 6 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | N-acetylcysteine amide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07290530 ↗ |
| Known as | NPI-001 | “N-acetylcysteine amide (NPI-001) tablets (250 mg), taken BID” NCT07290530 ↗ |
| Route | Oral | “Single dose, oral solution” NCT05994534 ↗ |