Organization (Industry)
BioDelivery Sciences International (United States)
ClinicalTrials.gov lists BioDelivery Sciences International (United States) as lead sponsor of 21 trials. It has 10 active development programs and 6 approved assets.
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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: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 0.2 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers BioDelivery Sciences International (United States): 21 lead-sponsored trials and 1 legal-entity registration. Part of COLLEGIUM PHARMACEUTICAL, INC.
Disease areas (22)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Pain | 16 |
| Back Pain | 6 |
| Chronic Pain | 6 |
| Low Back Pain | 6 |
| Substance-Related Disorders | 4 |
Showing 5 of 22 disease areas.
Trials by start year as sponsor or collaborator (12)
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 |
|---|---|
| 2022 | 1 |
| 2019 | 2 |
| 2016 | 2 |
| 2015 | 1 |
| 2014 | 2 |
| 2013 | 1 |
| 2012 | 5 |
| 2011 | 1 |
| 2010 | 1 |
| 2009 | 1 |
Showing 10 of 12 years.
Recruitment duration, a model prediction: none of the 21 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (10)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| DFN-15 Active | Migraine Disorders | Phase 3 | 2 |
| Naldemedine | Opioid-Induced Constipation | Not reported | 1 |
| Naldemedine | Constipation | Not reported | 1 |
| Naldemedine | Substance-Related Disorders | Not reported | 1 |
| Naloxegol | Opioid-Induced Constipation | Not reported | 1 |
Showing 5 of 10 active programs.
Approved assets (6)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Buprenorphine | 6 |
| Oxycodone | 2 |
| MORPHINE | 1 |
| Naldemedine | 1 |
| Naloxegol | 1 |
Showing 5 of 6 approved assets.
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 |
|---|---|
| 1 of 1 hit target (n=1) | 1 of 1 on time (n=1) |
Journals published in (5)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Advances in therapy | 1 |
| Clinical therapeutics | 1 |
| Journal of pain research | 1 |
| Pain and therapy | 1 |
| The Cochrane database of systematic reviews | 1 |
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 |
|---|---|---|
| 9 | 0 | 2018-02-27 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| VAI | 2 |
Organization relationships (1)
| Related organization | Relationship | Evidence |
|---|---|---|
| PRA Health Sciences | Uses vendor | 1 |
Latest dated events (31)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2022-08-03 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2021-05-21 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2019-07-23 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2019-04-24 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2019-01-04 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
Showing 5 of 31 events.
Biomarker capability evidence (18)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| COMMD3 | Trial sponsor | Named in trial inclusion criteria |
| MATN1 | Trial collaborator | Named in trial inclusion criteria |
| PPP1R12A | Trial sponsor | Primary endpoint in a Phase 3 trial |
| PPP1R12A | Trial sponsor | Primary endpoint in a Phase 3 trial |
| VEZF1 | Trial sponsor | Primary endpoint in a Phase 3 trial |
Showing 5 of 18 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, financing and grant events, fda warning letters, fda untitled letters, fda recalls, fda import refusals, manufacturing and distribution sites, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.