Drug Database
BU

buprenorphine

✓ Approved

Roche · OPRK1 · Small Molecule

What is buprenorphine?

buprenorphine is a small molecule developed by Roche. It is approved for therapeutic indications via oral (po) or sublingual (sl)/oral transmucosal.

Drug Profile

CompanyRoche
Drug ClassSmall Molecule
Molecular TargetOPRK1, OPRM1
RouteOral (PO), Sublingual (SL)/Oral Transmucosal
StatusApproved
Sources: ClinicalTrials.gov, Roche

Mechanism of Action

Molecular Targets

buprenorphine acts on 2 molecular targets:

OPRK1opioid receptor kappa 1 (KOR1, OPRK)
OPRM1opioid receptor mu 1 (MOR1, LMOR)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

buprenorphine is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Gastrointestinal disordersAbdominal pain✓ Approved

Related Research Articles

PubMedIndian journal of psychiatry2026-11-11

Fifteen years and beyond on buprenorphine maintenance: A descriptive case series from a community opioid agonist treatment clinic in North India.

Jadeer K Muhammed KM, Bano Hina H, Sarkar Siddharth S

Long-term outcome data on buprenorphine maintenance treatment beyond 15 years remain scarce, particularly from community-based treatment settings in low- and middle-income countries. We present a case series of five males with opioid use disorder on sublingual buprenorphine for 15 to 19 years at a North India community clinic were reviewed. All remained employed and showed improvement across health, family, social, and financial domains. Three had treatment interruptions, with relapse or withdrawal prompting re-engagement. All wished to continue treatment, and two preferred lifelong maintenance. This case series suggests that a sustained recovery is observed among patients who adhere to opioid agonist treatment for a prolonged period.

PMID 43011944
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PubMedInternational journal of surgery case reports2026-11-10

Mesenchymal chondrosarcoma of the sublingual space: a case report.

Jayawinata Yasser Y, Wibisana I Gusti Ngurah Gunawan IGNG, Ramadan Mohamad Rachadian MR, Rahadiani Nur N

Extraosseous mesenchymal chondrosarcoma (MCS) arising in the salivary space is an exceptionally rare malignancy, with only a few cases reported. The rarity of this entity poses significant challenges for clinicians. A 24-year-old female presented with a progressively enlarging mass in the floor of the mouth. Contrast-enhanced magnetic resonance imaging showed a heterogeneously enhancing mass in the left sublingual space with involvement of the genioglossus muscle. Wide local excision via a mandibulotomy approach was performed, with reconstruction using an anterolateral thigh (ALT) free flap. Surgical management of MCS in the oral cavity requires careful consideration of the approach and reconstructive options. The mandibulotomy approach provided excellent exposure for complete resection. Reconstruction with an ALT free flap offered soft-tissue coverage with satisfactory functional and esthetic outcomes. This case represents a primary MCS in the sublingual space. Complete surgical resection with long-term surveillance is essential to ensure survival and prevent recurrence.

PMID 43005790
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PubMedAdvanced science (Weinheim, Baden-Wurttemberg, Germany)2026-11-10

Spray-Dried mRNA-LNP Powder Enabling Multi-Route Delivery With 3-Year Refrigerated Stability.

Sarode Ashish A, Patel Priyal P, DeRosa Frank F, Karve Shrirang S et al.

The clinical translation of mRNA-lipid nanoparticle (mRNA-LNP) therapeutics is constrained by limited stability of liquid formulations, necessitating ultra-cold storage and restricting global accessibility. Here, we report a spray-dried dry powder platform for mRNA-LNPs that overcomes these limitations while enabling flexible routes of administration. Systematic evaluation of pharmaceutically relevant sugars identifies trehalose as an optimal matrix former, yielding high-recovery mRNA-LNP dry powder product (DPP) with controlled particle size, low residual moisture, and preserved LNP physicochemical properties upon reconstitution. Mechanistic studies combining solid-state characterization, fluorescence tracking, and solvent extraction demonstrate that mRNA-LNPs are entrapped within an amorphous trehalose matrix core, providing protection against dehydration and rehydration stress. Reconstituted DPP (RDPP) maintains in vivo protein expression comparable to liquid control (LC) following intravenous and intramuscular administration, while supporting effective mucosal delivery via pulmonary and sublingual routes. Direct administration of DPP without reconstitution enables lung-targeted protein expression, highlighting potential for cold-chain-independent therapies. Critically, DPP preserves colloidal stability, mRNA integrity, ionizable lipid stability, and biological activity for over 3 years under refrigerated conditions, whereas liquid formulation exhibits substantial degradation within 6-9 months. These findings establish spray-dried mRNA-LNP DPPs as a robust platform integrating long-term stability with multi-route delivery for improved accessibility of mRNA therapeutics.

PMID 43006795
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PubMedEuropean journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences2026-11-09

Automated Extrusion-based Dispensing of Mucoadhesive Oral Films Containing Buprenorphine for Feline Delivery to the Gingiva.

Lashkari T T, Ventoruzzo D D, Winter E A EA, van den Bogaard W J M WJM et al.

Cats are undertreated patients due to their lack of communication, with limited options for oral pain management, and may benefit from individualized oral dosage forms to facilitate at-home pain management. Buprenorphine would be a suitable treatment option with a proven safety profile. It is readily absorbed across the oral mucosa and acts, therefore, systemically. Extemporaneous formulations can be administered buccally to enable at-home treatment of pain, yet the poor palatability of formulations and highly variable absorption limit therapeutic effectiveness and regular clinical translation. However, preparing appropriately sized dosage forms for buprenorphine administration remains challenging. This study evaluated automated extrusion-based dispensing (AED), a simplified extrusion-based 3D printing, as an approach for preparing personalized mucoadhesive oral films (MFs) containing buprenorphine hydrochloride for gingival application in feline analgesia. A formulation consisting of CMC-Na, PEG 400, and water was identified as suitable for AED. The resulting films showed reproducible mass, uniform drug content, suitable pH, and rapid disintegration and drug release. In a preliminary administration trial with 39 cats, placebo MFs were retained at the gingival mucosa and were well accepted, supporting the feasibility of gingival application. Overall, AED enabled the preparation of personalized MFs for feline gingival administration, providing a basis for further development and evaluation of this dosage form.

PMID 43003154
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PubMedMicrobiology spectrum2026-11-09

Characterization of herpes B virus isolated from wild cynomolgus macaques and its pathogenic effects in captive hosts.

Sapkanarak Krittiga K, Kemthong Taratorn T, Suttisan Nutchanat N, Rattanamaneenin Chanaporn C et al.

Despite the high seroprevalence of herpes B virus (BV) among wild macaques, it remains unclear why BV is rarely transmitted to humans who live alongside macaques in their natural habitats. We investigated disease progression, host immune responses, viral shedding, histopathology, and immunohistochemistry of tissues after BV injection in cynomolgus macaques. BV was isolated from a wild Thai cynomolgus macaque living in southern Thailand and intramuscularly injected into four captive macaques (two males and two females) housed at the Animal Biosafety Level 3 facility. Over 49 days, all macaques remained clinically healthy but showed enlarged lymph nodes. IgM was detected on 9 days post-infection (dpi) and peaked at 13 dpi, while IgG appeared on 11 dpi and peaked at 28 dpi. No viral DNA was detected in oral, urogenital, or rectal swabs throughout the 49 day study period. However, viral DNA was identified in the spleen, sublingual gland, and trigeminal ganglia. Histopathology revealed tissue damage in the spleen and trigeminal ganglion, with BV immunoreactivity in the spleen. Overall, BV injection induces localized lymphoid and immune responses without causing clinical symptoms or viral shedding in natural macaque hosts. This may help explain why natural macaque hosts remain healthy and why human BV infections associated with wild cynomolgus macaques have rarely been documented.IMPORTANCEHerpes B virus (BV) isolated from a wild cynomolgus macaque was inoculated into captive macaques in an experimental setting. BV infection triggers localized lymphoid and immune responses (IgM and IgG) without causing clinical symptoms or viral shedding. Viral DNA was detected in the spleen, sublingual gland, and trigeminal ganglia. These insights improve our understanding of how BV interacts with its natural macaque hosts and shed light on the rare transmission of BV from wild macaques to humans.

PMID 43001806
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PubMedRespiratory medicine2026-11-09

House dust mite sublingual immunotherapy and rhinitis-related quality of life in biologic-controlled severe asthma: A propensity score-matched real-world study.

Hoshino Makoto M, Harada Tatsuhiko T, Kitamura Hiroshi H, Ootawa Junichi J

Whether house dust mite sublingual immunotherapy (HDM-SLIT) provides additional clinical benefits in patients with severe asthma already controlled by biologic therapy remains unclear. To evaluate the effects of add-on HDM-SLIT on rhinitis-related and asthma-related outcomes in patients with biologic-controlled severe asthma and allergic rhinitis. In this propensity score-matched real-world study, 86 patients with severe asthma and allergic rhinitis were analyzed after 1:1 matching of patients receiving HDM-SLIT with those receiving biologic therapy or continuing biologic therapy alone (43 patients per group). Changes in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ)-6, lung function, type 2 biomarkers, and airway structural parameters by quantitative computed tomography were evaluated over 12 months. Covariate-adjusted analyses and a sensitivity analysis restricted to patients receiving dupilumab were performed. RQLQ showed greater improvement with HDM-SLIT than with control (standardized mean differences [SMD] 1.545, 95% CI 0.910-2.180; p <0.001), and this finding remained significant in covariate-adjusted and dupilumab-restricted sensitivity analyses. AQLQ also improved with HDM-SLIT (SMD 0.673, 95% CI 0.097-1.250; p = 0.036). ACQ-6, FEV1% predicted, and percentage of airway wall area relative to total area (WA/Ao%) showed nominally greater improvements in the primary analyses (p = 0.023, 0.039, and 0.038, respectively). but these findings were not statistically significant after additional covariate adjustment. In patients with biologic-controlled severe asthma with allergic rhinitis, the most consistent benefit associated with add-on HDM-SLIT was improvement in rhinitis-related quality of life.

PMID 43003153
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