CLINICAL TRIALS PROFILE FOR NUBAIN

All Clinical Trials for NUBAIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00707824 ↗	Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus	Completed	Mahidol University	Phase 4	2000-06-01	Can epidural nalbuphine reduce incidence or severity of epidural morphine induced pruritus in patient undergoing cesarean section?
NCT00947284 ↗	Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity	Terminated	University of California, San Francisco	N/A	2010-01-01	In previous clinical studies of post-surgical pain the investigators found that nalbuphine (Nubain), a narcotic pain killer, relieves pain more effectively when combined with low-dose naloxone (Narcan), a drug that is used to treat narcotic overdose. This finding was particularly true in men. The purpose of this study is to find out if nalbuphine combined with naloxone is more effective in relieving experimentally produced pain than either drug alone. A second reason for this study is to find out if study medications work more effectively in women or in men. Subjects will come to the University of California at San Francisco (UCSF) Clinical Research Center (CRC) for 4 study visits. The first visit will be a 2-hour screening to assess the subject for study eligibility. During the other three visits, the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
NCT01380197 ↗	Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally	Completed	Atlanta Clinical and Translational Science Institute	Phase 3	2010-05-26	The pathophysiology of sickle cell disease (SCD) manifestations, are complex with interactions of intracellular hemoglobin, membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes are thought to result from ischemia caused when small blood vessels are occluded by misshapen, inflexible erythrocytes. Painful episodes are the most common cause of hospitalization, morbidity, and impairment for SCD patients. There is no therapy that completely prevents or directly aborts painful events for all patients. Consequently, treatment for acute VOC is primarily supportive using hydration and medicinal pain control. Every pain medication has the potential to relieve pain but is associated with significant limitations and side effects. The primary hypothesis to be tested in this double blind, randomized controlled trial is that Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes of acute chest syndrome. The investigators also expect subjects will report fewer side effects from respiratory depression, abdominal distention from reduced peristalsis, reduced histamine release causing pruritis and still be provided adequate pain control. Further hypotheses to be tested is ability to recruit patient participants while being treated in the Emergency Department and that continuous infusion of Nalbuphine with accompanying patient controlled analgesia (PCA) is safe and effective in controlling pain, requiring less total opiates consumption, while decreasing length of hospitalization.
NCT01380197 ↗	Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally	Completed	Children's Healthcare of Atlanta	Phase 3	2010-05-26	The pathophysiology of sickle cell disease (SCD) manifestations, are complex with interactions of intracellular hemoglobin, membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes are thought to result from ischemia caused when small blood vessels are occluded by misshapen, inflexible erythrocytes. Painful episodes are the most common cause of hospitalization, morbidity, and impairment for SCD patients. There is no therapy that completely prevents or directly aborts painful events for all patients. Consequently, treatment for acute VOC is primarily supportive using hydration and medicinal pain control. Every pain medication has the potential to relieve pain but is associated with significant limitations and side effects. The primary hypothesis to be tested in this double blind, randomized controlled trial is that Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes of acute chest syndrome. The investigators also expect subjects will report fewer side effects from respiratory depression, abdominal distention from reduced peristalsis, reduced histamine release causing pruritis and still be provided adequate pain control. Further hypotheses to be tested is ability to recruit patient participants while being treated in the Emergency Department and that continuous infusion of Nalbuphine with accompanying patient controlled analgesia (PCA) is safe and effective in controlling pain, requiring less total opiates consumption, while decreasing length of hospitalization.
NCT02820051 ↗	Non-anesthesiologist-administered Propofol During the Flexible Bronchoscopy	Completed	Hospital Universitario Dr. Jose E. Gonzalez	N/A	2014-02-01	Flexible bronchoscopy (FB) is a fundamental procedure for the diagnosis and treatment of respiratory diseases. Although midazolam is the recommended sedative agent by most guidelines, propofol has gained popularity due a short recovery time, however, evidence to propofol use for sedation during FB is scarce. There is little evidence about transcutaneous CO2 pressure (PtcCO2) behavior among patients sedated with propofol when it is administered by non-anesthesiologist and in combination with intravenous opioids for analgesia and cough inhibition. The investigators performed a randomized controlled trial to determine whether non-anesthesiology-administered balanced-sedation with propofol was related to high values of values of PtcCO2 compared with guideline-based sedation (midazolam and opioid). The investigators included data from outpatients 18 years or older with an indication for FB in a university hospital in northern of Mexico. Secondary outcomes were recuperation time, patient satisfaction and adverse effects.
NCT03034382 ↗	Morphine and/or Nalbuphine as Adjuvants in Ultrasound Guided Interscalene Block: for Shoulder Surgeries	Unknown status	Assiut University	Phase 2	2016-01-01	the aim of this study is to evaluate the duration of analgesia when either morphine or nalbuphine or both are used as adjuvants in sonar guided interscalene brachial plexus block for arthroscopic rotator cuff repair.
NCT04018664 ↗	Oral Abuse Potential Study of Nalbuphine	Completed	Syneos Health	Phase 1	2018-05-29	The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no active drug ingredients). The amount of nalbuphine levels in the blood will also be measured and the safety of the study drugs will be evaluated. This study has 2 parts: Part A and Part B.

Clinical Trial Conditions for NUBAIN

Condition Name

Condition Name for NUBAIN
Intervention	Trials
Cesarean Section	1
Conscious Sedation Failure During Procedure	1
Healthy	1
Nalbuphine	1

Condition MeSH

Condition MeSH for NUBAIN
Intervention	Trials
Anemia, Sickle Cell	1
Acute Chest Syndrome	1
Pruritus	1
Opioid-Related Disorders	1

Clinical Trial Locations for NUBAIN

Trials by Country

Trials by Country for NUBAIN
Location	Trials
United States	2
Canada	1
Thailand	1
Egypt	1
Mexico	1

Trials by US State

Trials by US State for NUBAIN
Location	Trials
Georgia	1
California	1

Clinical Trial Progress for NUBAIN

Clinical Trial Phase

Clinical Trial Phase for NUBAIN
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for NUBAIN
Clinical Trial Phase	Trials
Completed	4
Terminated	1
Unknown status	1

Clinical Trial Sponsors for NUBAIN

Sponsor Name

Sponsor Name for NUBAIN
Sponsor	Trials
Trevi Therapeutics	1
Mahidol University	1
University of California, San Francisco	1

Sponsor Type

Sponsor Type for NUBAIN
Sponsor	Trials
Other	7
Industry	1

Last updated: May 4, 2026

NUBAIN (Nalbuphine) Clinical Trials Update and Market Outlook

NUBAIN is the brand name for nalbuphine hydrochloride, an opioid receptor modulator used for analgesia. Public disclosures and major registry access patterns indicate limited visibility of active, late-stage clinical development for new nalbuphine indications in recent years, while the market remains driven by established hospital and inpatient use, procurement pricing, and generic competition.

---

What is NUBAIN and what is its clinical development position?

Drug identity

• Active ingredient: Nalbuphine hydrochloride
• Class: Mixed opioid agonist-antagonist (κ-opioid receptor agonist; μ-opioid receptor partial agonist/antagonist profile, depending on endpoint and receptor context)
• Primary use: Pain management (notably perioperative and inpatient settings)

Clinical trials update

A comprehensive, current “active-late-stage” picture for nalbuphine is constrained by the reality of its product lifecycle: nalbuphine has long-standing authorization in multiple markets, and the development focus has shifted toward label maintenance, formulation changes, and jurisdiction-specific studies, rather than large Phase 3 pivotal programs for new indications.

Across standard clinical-trial reporting channels, the most frequent patterns for nalbuphine are:

• Older Phase 3-era trials underpinning foundational indication approvals.
• Small to medium studies targeting pharmacokinetics, formulation, perioperative dosing comparisons, or safety monitoring.
• No consistent footprint of ongoing global Phase 3 programs that would indicate a near-term breakthrough indication expansion.

Net effect for decision-makers: the “clinical trials update” for NUBAIN is best treated as lifecycle maintenance, not as an engine for a new, investment-attractive late-stage pipeline.

---

How does the market work for nalbuphine (NUBAIN)?

Demand drivers

Nalbuphine demand tends to track:

• Hospital surgical volumes and perioperative analgesia protocols
• Inpatient pain management workflows
• Formulary decisions driven by opioid stewardship and payer contracting
• Availability and procurement reliability (supply continuity matters)

Key market constraints

• Generic competition: Nalbuphine is widely available as generics in many jurisdictions, which compresses branded pricing.
• Opioid regulation: Tightening national controls on opioid prescribing, storage, and reporting can affect channel throughput but rarely remove demand entirely due to clinical need.
• Substitution dynamics: Hospitals compare opioid options on efficacy, side-effect profile, sedation, and practical nursing administration needs.

---

Market analysis: current value pools and competitive landscape

Pricing and competitive structure

• Brand role: In many geographies, NUBAIN functions as an identified brand option in hospital procurement but faces pricing pressure from multiple generic entrants.
• Generic dominance: Where generics are established, tender-based contracting reduces room for premium pricing.
• Procurement model: Hospital systems often award supply by:
  • unit price,
  • distribution terms,
  • inventory readiness,
  • and compliance performance.

Positioning vs alternatives

In perioperative and inpatient pain management, nalbuphine competes with:

• other opioid analgesics used under similar protocols,
• mixed agonist-antagonists where available,
• and institution-specific opioid standard orders.

Because nalbuphine’s clinical footprint is long established, competitive shifts typically come from formulary revisions and procurement economics, not from new clinical differentiation.

---

What is the near-term market projection for NUBAIN?

Projection logic

For lifecycle products like nalbuphine, near-term market direction is governed by:

• generic price trends and tender competition,
• hospital admissions and surgical volumes,
• drug availability and supply stability,
• and regulatory adjustments affecting opioid handling.

Base case market trajectory (directional)

• Units: likely to remain stable to modestly declining in some markets where opioid stewardship encourages substitution, but not collapsing because nalbuphine stays embedded in perioperative analgesia practices.
• Revenue: likely flat to declining where branded pricing cannot keep pace with generic contraction; revenue may stabilize where branded share remains protected by specific contracting rules or limited supply moments.

Time horizon

• 0 to 24 months: dominated by procurement cycles and generic price pressure.
• 24 to 60 months: shaped by opioid policy adjustments and hospital formulary consolidation.

---

What clinical-trials activity should investors track for nalbuphine next?

Even when large Phase 3 programs are absent, decision-relevant signals typically come from:

• new dosing regimens or perioperative protocols backed by observational or small interventional studies,
• formulation work that affects manufacturability, shelf life, or stability,
• comparative safety work that supports formulary re-endorsement,
• jurisdictional label updates that open or protect specific procurement uses.

For NUBAIN, the practical investment question becomes less “is there a blockbuster Phase 3?” and more “does evidence support continued formulary acceptance in major purchasing systems?”

---

Regulatory and labeling anchor points that influence sales

Label-driven uptake

For established analgesics, uptake follows label clarity:

• route of administration and dosing schedules used in clinical pathways,
• warnings that affect institutional risk management,
• and any restrictions on patient populations.

Safety and opioid policy

Institutional opioid governance can increase monitoring requirements and tighten patient-selection criteria. This can reduce throughput for marginal cases but still supports continued use for standard analgesic needs.

---

Business implications by stakeholder

For pharmaceutical investors

• Treat NUBAIN as a mature analgesic with limited new indication catalyst risk.
• Focus on:
  • branded share versus generic share,
  • tender outcomes,
  • and supply continuity.

For R&D planners

• Pipeline value is more likely in incremental formulation or lifecycle stewardship than in new indications.
• If planning new development, the highest ROI tends to come from targeted perioperative pathways rather than broad analgesia repositioning.

For hospital procurement and formulary committees

• Evaluate nalbuphine as:
  • a procurement item subject to price competition,
  • and a protocol-driven analgesic with operational advantages (depending on local practice).

---

Key Takeaways

• NUBAIN (nalbuphine) is a mature opioid analgesic with clinical development that appears dominated by lifecycle maintenance rather than new late-stage pivotal programs.
• Market demand is anchored in hospital perioperative and inpatient pain management workflows.
• Revenue outlook is constrained by generic price pressure and tender-based contracting.
• Near-term market direction is expected to be stable to modestly down on units in some markets and flat to declining on branded revenue where generics dominate.
• Decision-making should prioritize procurement and formulary dynamics over expectation of a near-term breakthrough indication.

---

FAQs

1) Is NUBAIN expecting a major late-stage trial readout soon?

The development footprint for nalbuphine is consistent with lifecycle maintenance patterns rather than a clear, ongoing global Phase 3 pipeline for new indications.

2) What drives NUBAIN purchasing in hospitals?

Surgical volumes, inpatient pain management protocols, and procurement contracting terms typically drive utilization more than new clinical evidence.

3) How does generic competition impact NUBAIN pricing?

Generics typically compress branded pricing through tender awards and unit cost normalization, limiting revenue growth.

4) What is the main risk to market stability?

Shifts in opioid stewardship and formulary substitutions can reduce share, while supply continuity reduces disruption risk.

5) Where does value most likely persist for NUBAIN?

In settings where nalbuphine stays embedded in perioperative analgesia pathways and where contracted supply favors the product or limits alternate sourcing.

---

References

[1] FDA. “Drug Trials Snapshots” (nalbuphine / NUBAIN-related records). U.S. Food and Drug Administration.
[2] DailyMed. “NUBAIN (nalbuphine hydrochloride) injection” label and prescribing information. U.S. National Library of Medicine.
[3] ClinicalTrials.gov. “Nalbuphine” search results and trial records (ongoing and completed). U.S. National Institutes of Health.
[4] WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD classification reference for nalbuphine (where available). World Health Organization.