Organization (Industry)
Spark Biomedical, Inc. (United States)
ClinicalTrials.gov lists Spark Biomedical, Inc. (United States) as lead sponsor of 13 trials. It has 6 active development programs and 1 approved asset.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 3 registered with a 2026 start date. The dashed outline is the pace from the 2 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 2.8 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Spark Biomedical, Inc. (United States): 13 lead-sponsored trials and 1 legal-entity registration.
Disease areas (17)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Substance-Related Disorders | 9 |
| Opioid-Related Disorders | 6 |
| Hemorrhage | 4 |
| Substance Withdrawal Syndrome | 4 |
| Menorrhagia | 3 |
Showing 5 of 17 disease areas.
Trials by start year as sponsor or collaborator (8)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 3 |
| 2025 | 4 |
| 2024 | 3 |
| 2023 | 2 |
| 2022 | 3 |
| 2021 | 1 |
| 2020 | 1 |
| 2019 | 1 |
Recruitment duration, a model prediction: 2 trials still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (6)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Extended release injectable naltrexone (Vivitrol) | Opioid-Related Disorders | Not reported | 1 |
| Extended release injectable naltrexone (Vivitrol) | Substance Withdrawal Syndrome | Not reported | 1 |
| Extended release injectable naltrexone (Vivitrol) | Substance-Related Disorders | Not reported | 1 |
| Lofexidine | Opioid-Related Disorders | Not reported | 1 |
| Lofexidine | Substance Withdrawal Syndrome | Not reported | 1 |
Showing 5 of 6 active programs.
Approved assets (1)
| Drug | Trials |
|---|---|
| Lofexidine | 1 |
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 10% hit target (n=10) | 20% on time (n=10) |
Journals published in (31)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference | 2 |
| Applied ergonomics | 2 |
| Scientific reports | 2 |
| Sensors (Basel, Switzerland) | 2 |
| Annals of the New York Academy of Sciences | 1 |
Showing 5 of 31 journals.
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 12 | 10 | 2025-12-23 |
Financing and grant events (7)
Shown in this order: most recent first.
| Date | Round type | Amount (USD) | Source |
|---|---|---|---|
| 2025-08-26 | STTR award | 305,545 | Reporter |
| 2024-06-12 | SBIR award | 318,875 | Reporter |
| 2023-03-07 | Private placement | 16,234,159 | Form d |
| 2022-08-23 | SBIR award | 1,248,001 | Reporter |
| 2022-07-22 | SBIR award | 1,246,700 | Reporter |
Showing 5 of 7 events.
FDA recalls (1)
| Product | Classification | Initiated |
|---|---|---|
| Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28 | Class II | 2025-07-02 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Spark Biomedical Inc. | Richmond, US | FDA |
Organization relationships (1)
| Related organization | Relationship | Evidence |
|---|---|---|
| Five Liters, Inc. | Co sponsors trial with | 1 |
Latest dated events (38)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-10 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-03-06 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-01-28 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-12-23 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-11-11 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 38 events.
Biomarker capability evidence (14)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| CCNG1 | Trial collaborator | Named in trial inclusion criteria |
| COMMD3 | Trial collaborator | Named in trial inclusion criteria |
| TNFRSF17 | Trial sponsor | Named in trial inclusion criteria |
| F2 | Trial sponsor | Named in trial exclusion criteria |
| F3 | Trial sponsor | Named in trial exclusion criteria |
Showing 5 of 14 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, sec-reported annual financials, fda warning letters, fda untitled letters, fda inspection record, fda import refusals, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.