Nubain

(Nalbuphine)

ApprovedSmall molecule

Nalbuphine is used to relieve moderate to severe pain and is also used to reduce pain during anesthesia and surgery.[2] Nubain is currently approved and in use across 16 indications[4].[1]

Nubain is one of 300 small molecule programs targeting Cleft Palate. It is currently in Approved.

Indications

Total Trials

Active Trials

299

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Cleft PalateActive, not recruiting

MucositisActive, not recruiting

Shoulder PainActive, not recruiting

DeliriumApproved

Obstructive Sleep ApneaActive, not recruiting

HysterectomyActive, not recruiting

CataractActive, not recruiting

Inguinal HerniaActive, not recruiting

Breast CancerActive, not recruiting

Prurigo NodularisApproved

Cleft PalatePreclinical

Active, not recruiting

MucositisPhase 3

Active, not recruiting

Shoulder PainApproved

Active, not recruiting

DeliriumApproved

Approved

Obstructive Sleep ApneaPreclinical

Active, not recruiting

HysterectomyApproved

Active, not recruiting

CataractPhase 2

Active, not recruiting

Inguinal HerniaPreclinical

Active, not recruiting

Breast CancerPreclinical

Active, not recruiting

Prurigo NodularisApproved

Approved

Showing 10 of 12 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Nubain

AAultman Health Foundation

Approved

1 2

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 3

MS Contin

Merck & Co.

Preclinical

2 4

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 5

Chirocaine

PPurdue Pharma LP

Preclinical

1 6

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 7

Vfend

PPrism Pharmaceuticals

Preclinical

—8

Fentanyl Citrate

IINSYS Therapeutics Inc

Preclinical

2 9

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 10

Conventional Chemotherapy

SShanghai Jiao Tong University School of Medicine

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

N/ANot yet recruiting

Intravenous

NCT07422558

Q4 2026

Post-ApprovalRecruiting

Surgery

NCT06037330

Q2 2027

Phase 1Not yet recruiting

Orthopedic Surgery

NCT07279727

N/ANot yet recruiting

Breast Cancer

NCT07197684

Phase 2/3Not yet recruiting

Postoperative Pain Management

NCT06996561

Q4 2027

Post-ApprovalRecruiting

Postoperative Analgesia

NCT07269106

Clinical

Trials by Indication[1]

Agitation4 trials

Effect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries

Unknown status·—·Phase 1·NCT05245721·80 enrolled

Nalbuphine Versus Ketamine for Prevention of Emergence Agitation After Sevoflurane in Children Undergoing Tonsillectomy

Completed·—·Phase 4·NCT05176119·90 enrolled

Nalbuphine Versus Dexmedetomidine for Prevention of Emergence Agitation in Pediatrics

Unknown status·—·Phase 4·NCT05273671·126 enrolled

Show 1 more trial

Dexmedetomidine Versus Nalbuphine in Prevention of Emergence Agitation Following Adenotonsillectomy in Pediatrics

Unknown status·—·Phase 1/2·NCT04058899·120 enrolled

Cesarean Section3 trials

Intrathecal Nalbuphine Versus Midazolam in Cesarean Section

Completed·ZZagazig University·Phase 1·NCT03918187·90 enrolled

Comparison of IV Nalbuphine Versus Ibuprofen for Postoperative Pain Control in Cesarean Section

Completed·MMuhammad Aamir Latif·N/A·NCT06594224·80 enrolled

Intrathecal Midazolam, Fentanyl and Nalbuphine as Adjuvants to Bupivacaine in Spinal Anesthesia for Cesarean Section

Completed·—·N/A·NCT04932083·100 enrolled

Postoperative Analgesia3 trials

Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery

Recruiting·ZZhongshan Ophthalmic Center, Sun Yat-sen University·Phase 4·NCT07269106·204 enrolled

Nalbuphine Versus Tramadol on Post Operative Analgesia in Abdominal Surgery on Pediatric Cancer Patient

Recruiting·NNational Cancer Institute, Egypt·N/A·NCT07110051·128 enrolled

Comparsion Between Intrathecal Fentanyl and Intravenous Nalbuphine As a Postoperative Analgesia in Lower Limb Surgeries

Not yet recruiting·—·Phase 4·NCT06720506·100 enrolled

Dexmedetomidine3 trials

Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia

Completed·—·Phase 2·NCT05327088·64 enrolled

Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine

Completed·MMansoura University·N/A·NCT05347173·60 enrolled

Epidural Nalbuphine Versus Dexmedetomidine as Adjuvants to Bupivacaine in Lower Limb Surgeries

Completed·ZZagazig University·N/A·NCT05041270·23 enrolled

Erector Spinae Plane Block2 trials

Erector Spinae Plane Block for Analgesia During ESWL

Recruiting·SSohag University·N/A·NCT07067996·60 enrolled

Erector Spinae Plane Block Versus Opioid Based General Anesthesia During Laparoscopic Bariatric Surgery

Completed·—·N/A·NCT03798522·28 enrolled

30 more indications

Surgery2 trials

Nalbuphine and Flurbiprofen for Oculoplastic Surgery

Completed·SSun Yat-sen University·N/A·NCT03422887·330 enrolled

Nalbuphine in ARDS Patients After Surgery

Recruiting·HHairong Chen·Phase 4·NCT06037330·60 enrolled

Bupivacaine2 trials

Nalbuphine Plus Caudal Bupivacaine in Hypospadius Repair

Completed·—·N/A·NCT03476772·60 enrolled

Analgesic Additives to Epidural Bupivacaine in Normal Labor

Unknown status·—·N/A·NCT05746351·69 enrolled

Cataract2 trials

Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery

Completed·—·N/A·NCT03436836·40 enrolled

Conscious Sedation for Cataract Operations Under Topical Anaesthesia

Completed·MMenoufia University·Phase 2·NCT03933280·100 enrolled

Pruritus2 trials

Nalbuphine for the Treatment of Opioid Induced Pruritus in Children

Completed·UUniversity of British Columbia·Phase 3·NCT00323154·134 enrolled

Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus

Completed·MMahidol University·Phase 4·NCT00707824·165 enrolled

Laparoscopic Cholecystectomy2 trials

Comparative Study of Opioid-Free Anesthesia Versus Opioid Anesthesia in Patients Undergoing Laparoscopic Cholecystectomy

Not yet recruiting·—·Phase 4·NCT06736496·100 enrolled

Comparison of the Efficacy of Intraperitoneal Instillation of Fentanyl Versus Nalbuphine As Adjuvants to Bupivacaine for Postoperative Pain Relief in Patients Undergoing Laparoscopic Cholecystectomy

Not yet recruiting·—·Phase 4·NCT06722963·70 enrolled

Postoperative Pain Management1 trial

Exploring the Impact of Genetic Variations on The Clinical Efficacy of Nalbuphine in Postoperative Pain Management

Not yet recruiting·—·Phase 2/3·NCT06996561·263 enrolled

Mucositis1 trial

Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients

Completed·—·Phase 3·NCT03825887·80 enrolled

Intravenous1 trial

Intravenous Nalbuphine Versus Lidocaine for Prevention of Propofol Injection Pain

Not yet recruiting·HHayatabad Medical Complex·N/A·NCT07422558·92 enrolled

Ablation1 trial

Nalbuphine Versus Morphine for Perioperative Tumor Ablation

Unknown status·ZZhongda Hospital·Phase 4·NCT05073744·316 enrolled

Laryngoscopy1 trial

Effect of Nalbuphine Versus Fentanyl on Hemdoynamic Effects of Laryngoscopy

Recruiting·—·Phase 4·NCT07435337·98 enrolled

Rectus Sheath Block1 trial

The Application of Transversus Abdominis Plane Block Plus Rectus Sheath Block in Clinical Anesthesia

Unknown status·TThe First Affiliated Hospital of Anhui Medical University·N/A·NCT02984865·190 enrolled

Intranasal Administration1 trial

Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants

Terminated·UUniversity Children's Hospital, Zurich·Phase 1·NCT03059511·51 enrolled

Interscalene Block1 trial

Morphine and/or Nalbuphine as Adjuvants in Ultrasound Guided Interscalene Block: for Shoulder Surgeries

Unknown status·—·Phase 2·NCT03034382·80 enrolled

Oral1 trial

The Development of Oral Nalbuphine Dosage Form

Unknown status·TTri-Service General Hospital·N/A·NCT00924079·60 enrolled

Shoulder pain1 trial

Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain

Completed·UUniversity of Debrecen·Phase 4·NCT02445599·3 enrolled

Hysterectomy1 trial

Intraperitoneal Bupivacaine With Magnesium or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy

Completed·—·Phase 4·NCT03393572·80 enrolled

Pain and Discomfort1 trial

Postoperative Pain and Discomfort After Orbital Decompression

Completed·SSun Yat-sen University·N/A·NCT03562611·63 enrolled

Laparoscopic1 trial

Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy

Unknown status·PPeking University First Hospital·Phase 4·NCT03288428·80 enrolled

Bronchoscopy1 trial

Non-anesthesiologist-administered Propofol During the Flexible Bronchoscopy

Completed·HHospital Universitario Dr. Jose E. Gonzalez·N/A·NCT02820051·102 enrolled

Interaction1 trial

Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs

Unknown status·TTri-Service General Hospital·Phase 1·NCT00923000·50 enrolled

Analgesic1 trial

The Effect of Analgesic Drugs on Respiratory Center

Unknown status·CChun Pan·Phase 4·NCT04372342·50 enrolled

Tics1 trial

Pharmacokinetics of Nalbuphine Injection

Completed·YYung Shin Pharm. Ind. Co., Ltd.·Phase 4·NCT03826316·14 enrolled

Analgesia1 trial

Analgesia Effects of Nalbuphine vs Sulfentanil

Unknown status·FFudan University·N/A·NCT02604797·80 enrolled

TED1 trial

The 90% Effective Dose of Nalbuphine in Mechanical Ventilated Patients in the ICU

Unknown status·HHua-Qing Shu·Phase 4·NCT03786887·60 enrolled

Breast Cancer1 trial

Ultrasound Guided Pecs Block and Ketamine Infusion for Preventing Chronic Pain in Patients Undergoing Breast Cancer Surgery

Not yet recruiting·—·N/A·NCT07197684·120 enrolled

Sedation1 trial

Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery

Recruiting·UUniversity Medical Centre Ljubljana·N/A·NCT07340008·60 enrolled

Cleft Palate1 trial

Nalbuphine as Adjuvant During Bilateral Suprazygomatic Maxillary Nerve Block for Pediatric Cleft Palate Repair

Active, not recruiting·—··NCT06100315·60 enrolled

Orthopedic Surgery1 trial

Ultrasound-Guided Infraclvicular Block Using Dexmedetomidine Versus Nalbuphine as Adjuvants to Bupivacaine in Upper Limb Orthopedic Surgery

Not yet recruiting·—·Phase 1·NCT07279727·66 enrolled

Regional Anesthesia1 trial

Nalbuphine as an Adjuvant to Intravenous Regional Anesthesia

Completed·—·N/A·NCT02678585·106 enrolled

Surgical Procedure, Unspecified1 trial

Opioid-based (OA) Versus Opioid-free Anaesthesia (OFA) for General Surgical Procedures in a Developing Country

Completed·AAtif Shafqat·Preclinical·NCT06476600·42 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

NUBAIN

NDA NDA018024

Mar 12, 1993

NALBUPHINE HYDROCHLORIDE

NDA NDA020200

Sources

References

[1]
ClinicalTrials.gov — 50 trial records for Nalbuphine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nubain drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nalbuphine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nalbuphine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020200). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Aultman Health Foundation company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Opioid Receptors; Mu/kappa/delta Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAultman Health Foundation

Nubain

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q2 2027

Q4 2027

Trials by Indication[1]

Agitation4 trials

Cesarean Section3 trials

Postoperative Analgesia3 trials

Dexmedetomidine3 trials

Erector Spinae Plane Block2 trials

Surgery2 trials

Bupivacaine2 trials

Cataract2 trials

Pruritus2 trials

Laparoscopic Cholecystectomy2 trials

Postoperative Pain Management1 trial

Mucositis1 trial

Intravenous1 trial

Ablation1 trial

Laryngoscopy1 trial

Rectus Sheath Block1 trial

Intranasal Administration1 trial

Interscalene Block1 trial

Oral1 trial

Shoulder pain1 trial

Hysterectomy1 trial

Pain and Discomfort1 trial

Laparoscopic1 trial

Bronchoscopy1 trial

Interaction1 trial

Analgesic1 trial

Tics1 trial

Analgesia1 trial

TED1 trial

Breast Cancer1 trial

Sedation1 trial

Cleft Palate1 trial

Orthopedic Surgery1 trial

Regional Anesthesia1 trial

Surgical Procedure, Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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