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DFN-15 Active — Competitive Intelligence Brief
phase 3
Partial mu-opioid receptor agonist
Mu-opioid receptor (μ-OR)
Pain Management
Small molecule
Live · refreshed every 30 min
Target snapshot
DFN-15 Active (DFN-15 Active) — BioDelivery Sciences International. DFN-15 is a buprenorphine sublingual tablet formulation designed to provide rapid onset and consistent opioid receptor agonism for pain management.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| DFN-15 Active TARGET | DFN-15 Active | BioDelivery Sciences International | phase 3 | Partial mu-opioid receptor agonist | Mu-opioid receptor (μ-OR) | |
| Subutex, Buprenorphine Hydrochloride, SCH 28444 | Subutex, Buprenorphine Hydrochloride, SCH 28444 | Indivior Inc. | marketed | Partial mu-opioid receptor agonist | Mu-opioid receptor (μ-OR) | |
| Buprenorphine (Experimental) | Buprenorphine (Experimental) | University of Alabama at Birmingham | marketed | Partial mu-opioid receptor agonist | Mu-opioid receptor (μ-OR) | |
| Buprenorphine Buccal Film [Belbuca] | Buprenorphine Buccal Film [Belbuca] | Carolinas Pain Institute | marketed | Partial mu-opioid receptor agonist | Mu-opioid receptor (μ-OR) | |
| Use of buprenorphine with FAO > 30 OME | Use of buprenorphine with FAO > 30 OME | Fox Chase Cancer Center | marketed | Partial mu-opioid receptor agonist | Mu-opioid receptor (μ-OR) | |
| Buprenorphine SL | Buprenorphine SL | New York State Psychiatric Institute | marketed | Partial mu-opioid receptor agonist | Mu-opioid receptor (μ-OR) | |
| Immediate Release Sublingual Buprenorphine | Immediate Release Sublingual Buprenorphine | Royal Victoria Hospital, Canada | marketed | Partial mu-opioid receptor agonist | Mu-opioid receptor (μ-OR) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Partial mu-opioid receptor agonist class)
- Indivior Inc. · 3 drugs in this class
- New York State Psychiatric Institute · 3 drugs in this class
- Orexo AB · 2 drugs in this class
- BioDelivery Sciences International · 2 drugs in this class
- King's College London · 1 drug in this class
- Merck Sharp & Dohme LLC · 1 drug in this class
- Mundipharma (China) Pharmaceutical Co. Ltd · 1 drug in this class
- NYU Langone Health · 1 drug in this class
- National Institute on Drug Abuse (NIDA) · 1 drug in this class
- Purdue Pharma LP · 1 drug in this class
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- DFN-15 Active CI watch — RSS
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- DFN-15 Active CI watch — JSON
- DFN-15 Active alone — RSS
- Whole Partial mu-opioid receptor agonist class — RSS
Cite this brief
Drug Landscape (2026). DFN-15 Active — Competitive Intelligence Brief. https://druglandscape.com/ci/dfn-15-active. Accessed 2026-05-13.
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