COMPANY
Amydis Diagnostics
Funding and NIH signals
- NIH award NIH awarded $1.11M (SBIR Phase II 5R44AG078075-03, continuation, notice Jul 10, 2026). NIH RePORTER 5R44AG078075-03 (Jul 10, 2026)
Evidence (1 event)
- Jul 10, 2026 · NIH RePORTER 5R44AG078075-03
Organization: AMYDIS DIAGNOSTICS, INC.; City/State: La Jolla, CA; Project number: 5R44AG078075-03; Activity code: R44; Fiscal year: 2026; Award notice date: 2026-07-10; FY total cost (award amount): 1107817; Administering IC: National Institute on Aging; Project title: Development of a topical tracer to detect TDP43 in ALS, LATE and FTD retinas for AI-powered disease insights; Organization type: Domestic For-Profits
- Jul 10, 2026 · NIH RePORTER 5R44AG078075-03
Timeline
- Grant Government grant — SBIR: $1.11M (annual award, as published), announced Jul 10, 2026. Agency: NIH/NIA. Source: government award database. source ↗
- Grant Government grant — SBIR: $1.39M (annual award, as published), announced Sep 9, 2025. Agency: NIH/NIA. Source: government award database. source ↗
- Trial start Phase 2: A Study of AMDX-2011P in Participants With Alzheimer's Disease source ↗
- Trial start Phase 2: A Study of AMDX-2011P in Participants With CAA source ↗
- Trial start Phase 2: A Study of AMDX-2011P in Participants With Primary Open Angle Glaucoma source ↗
- Trial start Phase 1/Phase 2: Study of AMDX-2011P as a Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic Proteinopathy source ↗
Upcoming milestones
- 2026-12 (ESTIMATED) · Phase 2 · A Study of AMDX-2011P in Participants With CAA · NCT05709314
- 2027-07 (ESTIMATED) · Phase 2 · A Study of AMDX-2011P in Participants With Alzheimer's Disease · NCT06514001
Funding
Clinical trials (lead sponsor) 4
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06514001 | A Study of AMDX-2011P in Participants With Alzheimer's Disease | Phase 2 | Recruiting | Mar 7, 2025 | 2027-07 (estimated) |
| NCT05709314 | A Study of AMDX-2011P in Participants With CAA | Phase 2 | Recruiting | Jul 9, 2024 | 2026-12 (estimated) |
| NCT05542576 | Study of AMDX-2011P as a Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic Proteinopathy | Phase 1/Phase 2 | Completed | Aug 24, 2022 | Mar 15, 2023 (actual) |
| NCT06223048 | A Study of AMDX-2011P in Participants With Primary Open Angle Glaucoma | Phase 2 | Unknown status (ClinicalTrials.gov) | Dec 7, 2023 | 2024-11 (estimated) |
NIH awards 15
- NIH award 5SB1AG050454-05 FY2024: $1,715,680 awarded for that fiscal year; activity SB1 (SBIR); PI SARRAF, STELLA; recipient as written: AMYDIS DIAGNOSTICS, INC., La Jolla, CA. Use of novel fluorescent tracers to dev source ↗
- NIH award 2SB1AG050454-04A1 FY2023: $1,704,372 awarded for that fiscal year; activity SB1 (SBIR); PI SARRAF, STELLA; recipient as written: AMYDIS DIAGNOSTICS, INC., La Jolla, CA. Use of novel fluorescent tracers to d source ↗
- NIH award 5R44NS124473-02 FY2022: $900,109 awarded for that fiscal year; activity R44 (SBIR); PI SARRAF, STELLA; recipient as written: AMYDIS DIAGNOSTICS, INC., La Jolla, CA. Differential diagnosis of Parkinson's and source ↗
- NIH award 1R43AG078075-01 FY2022: $458,527 awarded for that fiscal year; activity R43 (SBIR); PI SARRAF, STELLA; recipient as written: AMYDIS DIAGNOSTICS, INC., La Jolla, CA. Development of a novel fluorescent tracer source ↗
- NIH award 5SB1AG073029-02 FY2022: $1,442,787 awarded for that fiscal year; activity SB1 (SBIR); PI SARRAF, STELLA; recipient as written: AMYDIS DIAGNOSTICS, INC., La Jolla, CA. Development of an ophthalmic diagnostic source ↗
- NIH award 1R44NS124473-01 FY2021: $2,077,573 awarded for that fiscal year; activity R44 (SBIR); PI SARRAF, STELLA; recipient as written: AMYDIS DIAGNOSTICS, INC., La Jolla, CA. Differential diagnosis of Parkinson's a source ↗
- NIH award 1R43AG071089-01A1 FY2021: $492,212 awarded for that fiscal year; activity R43 (SBIR); PI SARRAF, STELLA; recipient as written: AMYDIS DIAGNOSTICS, INC., La Jolla, CA. Development of Novel Tau Retinal Tracer source ↗
- NIH award 1SB1AG073029-01A1 FY2021: $1,590,883 awarded for that fiscal year; activity SB1 (SBIR); PI SARRAF, STELLA; recipient as written: AMYDIS DIAGNOSTICS, INC., La Jolla, CA. Development of an ophthalmic diagnost source ↗
- NIH award 5R44AG058350-03 FY2020: $1,049,456 awarded for that fiscal year; activity R44 (SBIR); PI SARRAF, STELLA; recipient as written: AMYDIS DIAGNOSTICS, INC., La Jolla, CA. Development of a novel ophthalmic probe source ↗
- NIH award 2R44AG058350-02 FY2019: $490,250 awarded for that fiscal year; activity R44 (SBIR); PI SARRAF, STELLA; recipient as written: AMYDIS DIAGNOSTICS, INC., La Jolla, CA. Development of a novel ophthalmic probe f source ↗
- NIH award 1R43AG057421-01A1 FY2018: $408,225 awarded for that fiscal year; activity R43 (SBIR); PI SARRAF, STELLA; recipient as written: AMYDIS DIAGNOSTICS, INC., La Jolla, CA. Development of Novel Prion Disease Diag source ↗
- NIH award 1R43AG058350-01 FY2017: $534,525 awarded for that fiscal year; activity R43 (SBIR); PI SARRAF, STELLA; recipient as written: AMYDIS DIAGNOSTICS, INC., La Jolla, CA. Development of a Novel Diagnostic Probe f source ↗
- NIH award 5R44AG050454-03 FY2017: $211,174 awarded for that fiscal year; activity R44 (SBIR); PI SARRAF, STELLA; recipient as written: AMYDIS DIAGNOSTICS, INC., La Jolla, CA. Development of an ophthalmic diagnostic p source ↗
- NIH award 2R44AG050454-02 FY2016: $1,647,908 awarded for that fiscal year; activity R44 (SBIR); PI SARRAF, STELLA; recipient as written: AMYDIS DIAGNOSTICS, INC., La Jolla, CA. Development of an ophthalmic diagnostic source ↗
- NIH award 1R43AG050454-01A1 FY2015: $383,810 awarded for that fiscal year; activity R43 (SBIR); PI SARRAF, STELLA; recipient as written: AMYDIS DIAGNOSTICS, INC., La Jolla, CA. Development of an ophthalmic diagnostic source ↗