Drugs / ADV7103
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | Sibnayal | distal renal tubular acidosis | — | “Its lead product Sibnayal® (ADV7103) has received its Marketing Approval f or distal renal tubular acidosis in EU, GB, KSA and UAE, and has been filed for a US NDA.” advicenne.com ↗ “Advicenne submitted the registration application for ADV7103 to the Food and Drug Administration (FDA) in November 2025.” advicenne.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07446881 | Feb → Mar 2025 | distal renal tubular acidosis | Advicenne Pharma | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03831152 | Dec 2023 → Jan 2025 | renal tubular acidosis | Advicenne Pharma | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy3 trials | ||||||
| Phase 2/3 | NCT04137978 Comparator | May 2024 → Jun 2025 | cystinuria | Advicenne Pharma | Withdrawn | No outcome recorded Stop: Business |
| Phase 2/3 | NCT04147871 Comparator | Mar 2024 → May 2025 | cystinuria | Advicenne Pharma | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT03644706 Comparator | Sep 2021 → Dec 2023 | distal renal tubular acidosis | Advicenne Pharma | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-08-31 | Advicenne Pharma | Regulatory Advicenne decides to withdraw its ADV7103 New Drug Application in the USA advicenne.com ↗
Advicenne (Euronext Growth Paris - FR0013296746 - ALDVI), a pharmaceutical company specializing in the development and marketing of innovative treatments for people suffering from rare kidney diseases, announces today the voluntary withdrawal of the New Drug Application ( NDA) for ADV7103 in the treatment of primary distal Renal Tubular Acidosis (dRTA) in the USA. |
| 2026-07-01 | Advicenne Pharma | Regulatory Advicenne announces the unlimited renewal of the Marketing Authorization for Sibnayal® in the United Kingdom advicenne.com ↗
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted the unlimited renewal of MA for Sibnayal® effective June 2026. |
| 2026-01-19 | Advicenne Pharma | Regulatory Advicenne: FDA has accepted for review the Marketing Authorization Application for Sibnayal® in the United States for the treatment of dRTA advicenne.com ↗ |
| 2025-08-26 | Advicenne Pharma | Results Advicenne announces the publication in Orphanet Journal of Rare Diseases of the long-term European study results of dRTA treatment using ADV7103 advicenne.com ↗ |
| 2025-07-28 | Advicenne Pharma | Regulatory Advicenne receives marketing authorization and reimbursement for Sibnayal® in Saudi Arabia advicenne.com ↗
Marketing authorization for Sibnayal® (ADV7103) in distal Renal Tubular Acidosis (dRTA) in KSA has been granted, based on the European registration dossier. |
| 2025-01-29 | Advicenne Pharma | Regulatory Advicenne reaches a significant milestone with the US FDA in the development of ADV7103 in cystinuria advicenne.com ↗
Following this meeting, the FDA accepted Advicenne’s proposition of a biological primary endpoint for the evaluation of ADV7103 in cystinuria ; a significant step in preparing for a clinical trial of limited duration and number of patients. |
| 2024-03-28 | Advicenne Pharma | Regulatory Strong improvement of 2023 results thanks to sustained commercial activity on Sibnayal® advicenne.com ↗
Major announcement post-closing: US Orphan Drug Designation of ADV7103 in cystinuria. |
| 2024-03-25 | Advicenne Pharma | Regulatory FDA grants Orphan Drug Designation to ADV7103 for the treatment of cystinuria advicenne.com ↗ |
| 2022-12-13 | Advicenne Pharma | Regulatory Advicenne obtains Orphan Drug Designation for ADV7103 in the United States for the treatment of distal Renal Tubular Acidosis (dRTA) advicenne.com ↗ |
All press releases naming this drug 10 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ADV7103 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03644706 ↗ |
| Route | Oral | “single oral dose of ADV7103” NCT07446881 ↗ |