TheraRadar
Data updated: May 26, 2026

IGALMI (dexmedetomidine hydrochloride)

Adrenergic alpha2-Agonists Trial Activity: Mature 108 active trials
CNS Approved 2022-04-05

IGALMI is a central alpha-2 adrenergic agonist indicated for the acute treatment of agitation in adults. It is used for patients diagnosed with schizophrenia or bipolar I or II disorder. The therapeutic role of this medication is limited to short-term intervention, as its safety and effectiveness have not been established beyond 24 hours from the initial dose.

Source: FDA Label • BIOXCEL • Central alpha-2 Adrenergic Agonist
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How IGALMI Works

Dexmedetomidine, the active ingredient in IGALMI, functions as an alpha-2 adrenergic receptor agonist. The drug's therapeutic effect in treating acute agitation is believed to result from the activation of presynaptic alpha-2 adrenergic receptors. By targeting these specific receptors, the medication modulates physiological pathways to manage agitation associated with psychiatric disorders.

Source: FDA Label

Development Insights

Assiut University conducting 43 trials (9%)
546 indications explored (Broad Platform)
→ dexmedetomidine (44 trials)
→ anesthesia (30 trials)
→ delirium (23 trials)
2
Indications
--
Phase 3 Trials
4
Years on Market

Details

Status
Prescription
First Approved
2022-04-05
PDUFA Date
2026-11-14 (172d)
Patent Cliff
2043

Pro Metrics

Patent cliff and revenue data

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Routes
BUCCAL, SUBLINGUAL
Dosage Forms
FILM

Companies

BIOXCEL
Active Ingredient: DEXMEDETOMIDINE HYDROCHLORIDE

IGALMI Approval History

2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2022 to 2025 · 1 indication expansions
Nov 2025 SUPPL
Efficacy
FDA Letter Label
Oct 2022 SUPPL
Label · Labeling
FDA Letter
Apr 2022 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What IGALMI Treats

3 indications

IGALMI is approved for 3 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Agitation
  • Schizophrenia
  • Bipolar Disorder
Source: FDA Label

IGALMI Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

10

Same target(s), different indications — where else is this mechanism being explored?

LOFEXIDINE HYDROCHLORIDE
MSN
2024 1 indic.
RYZUMVI
FAMYGEN LIFE
2023 1 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

SUBVENITE
OWP PHARMS
2025 5 indic.
COBENFY
Bristol-Myers Squibb
2024 1 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to IGALMI

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ZIPRASIDONE MESYLATE
ZIPRASIDONE MESYLATE
3 shared
MSN
Shared indications:
SchizophreniaBipolar DisorderAgitation
CAPLYTA
LUMATEPERONE TOSYLATE
2 shared
INTRA-CELLULAR
Shared indications:
SchizophreniaBipolar Disorder
LATUDA
LURASIDONE HYDROCHLORIDE
2 shared
SUNOVION PHARMS INC
Shared indications:
SchizophreniaBipolar Disorder
View all 20 similar drugs Pro
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Clinical Trial Registry

487 trials
Trial Sponsor ID Phase Status Title
NCT03317067 4D results posted CHU- 356 2017-000731-14 Ph 3 completed Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial)
NCT07179913 esketamine 2025-185 Ph 4 active not recruiting The Improvement of Low-dose Esketamine on Postoperative Depression in Patients Undergoing Bariatric Surgery With Preoperative Depression
NCT04928391 17300616 Ph 3 completed A Single Bolus of Dexmedetomidine Versus Normal Saline in Postoperative Agitation
NCT05705128 Any Assiut anesthesia g35 Ph 2, Ph 3 enrolling by invitation Dexmedetomidine in Postoperative Analgesia
NCT06490731 New valley anesthesia 4 Ph 1, Ph 2 recruiting Effects of Dexmedetomidine Versus Ketamine on Inflammatory Response and Hemodynamic in Patients
NCT07570160 PEDI-NPOBCs 202512066-2 SWYY2025002065 Ph 4 not yet recruiting Intranasal Dexmedetomidine or Esketamine for Negative Postoperative Behavioral Changes in Children
NCT07567495 ACYY0438 Ph 4 not yet recruiting Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
NCT07550881 DEX-AAS-2601 Ph 2 not yet recruiting Intranasal Dexmedetomidine for Acute Anxiety State in Adults
NCT07557680 SIUT-ERC-2024/A-488 Ph 3 completed Dexmedetomidine in Attenuation of Haemodynamic Response to Laryngoscopy in Controlled Hypertensive Patients
NCT07556523 IRB2025-0154 Ph 4 recruiting Patient Quality of Recovery After TAVR With Different Sedation Regimens
NCT04656470 results posted 2019P000996 Ph 2, Ph 3 completed Neuroimaging Study of Dexmedetomidine-Induced Analgesia
NCT07544173 IndonesiaU260226 Ph 4 completed Intravenous Magnesium Sulphate Versus Dexmedetomidine for Prevention of Emergence Agitation in Adult Otorhinolaryngologic Surgery
NCT07542990 PEDIADEX PEDIADEX Ph 3 not yet recruiting Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care
NCT07538284 MIDDIES 2025ZSLYEC-227 Ph 2, Ph 3 not yet recruiting MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES)
NCT07462195 DEX-THYROID DEX-THYROID-RCT-2025 Ph 4 recruiting Dexmedetomidine for Improving Emergence Quality in Thyroid Surgery
NCT06789016 12/2024 Ph 4 completed Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery
NCT07306702 DEX-PCIA SYCHS6-LOB-PCIA-RCT-2023 JUH-CCP-RC-RETRO-01 Ph 4 withdrawn Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients
NCT07377981 EDNID 2025-SR-1088 Ph 4 not yet recruiting An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyperactive Delirium: Protocol of a Randomized Controlled Trial
NCT07308756 2025-0455 Ph 4 recruiting Impact of Perioperative Dexmedetomidine and Esketamine on Postoperative Quality of Recovery
NCT06148311 22-01332 1R01FD007826-01 Ph 2 enrolling by invitation Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia
NCT05619627 STUDY00002526 Ph 1 not yet recruiting Oral Dexmedetomidine in Pediatric MRI
NCT05072704 OFATHA 2021/04 Ph 3 completed Opioid Free Anesthesia in Total Hip Arthroplasty
NCT06480539 DEXSLEEP Z-2023104 Ph 4 recruiting The Effect of Nocturnal Dexmedetomidine on Postoperative Sleep Quality and Fatigue After Major Surgery in Elderly Patients: DEXSLEEP Study
NCT03834129 DIVA 2018/08 Ph 3 completed Dexmedetomidine Intra Venous Arthroplasty
NCT07513935 FMASU R51/2026 Ph 4 active not recruiting Comparison of Combined Dexmedetomidine and Ketamine (Ketodex) Versus Dexmedetomidine Alone in Awake Mapping for Deep Brain Stimulation: A Randomized Controlled Trial
NCT07510217 36264PR789/7/24 Ph 2 completed ERAS Approach for Post-Craniotomy Headache and Psychological Recovery
NCT07508202 F52/2024(ERRC)/PIMS Ph 4 recruiting Comparison of Post Operative Analgesia in Patients Undergoing Lower Abdominal Surgeries Receiving Ultrasound Guided Block With Dexmetomidine vs Dexmethasone
NCT06093893 H-43663 Ph 4 completed Hypotensive Anesthesia for Orthognathic Surgery
NCT06470100 107/24 Ph 4 completed Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Knee Arthroplasty
NCT05321121 results posted 20216525 Ph 4 completed Dexmedotomidine for Acute Pain Control in Patients With Multiple Rib FracturesRandomized Controlled Trial
NCT04266665 DexProB Ph 4 completed Effect of Dexmedetomidine on Brain Homeostasis and Neurocognitive Outcome
NCT07316166 2264738 Ph 4 recruiting Suprainguinal Fascia Iliaca Block With vs Without Dexmedetomidine
NCT05446623 OFFLOW 2020-A02873-36 Ph 2, Ph 3 completed Cardiac Index and General Anesthesia Without Opioid.
NCT07184801 DEMISE-MT IEC-INT/2025/DM-2480 Ph 3 recruiting Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy
NCT04772222 DICE results posted 136561 Ph 2 completed Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
NCT07432997 AC.2023.01 Ph 1, Ph 2 completed Pharmacological Enhancement of Glymphatic Function in Humans
NCT07425444 stress in lap cholecystectomy Ph 4 not yet recruiting Attenuate the Stress Response in Laparoscopic Cholecystectomy
NCT06453681 PECs MD-75-2024 Ph 4 completed Dexmedetomidine as an Adjuvant to Bupivacaine in Bilateral PECs for Pain Control After Cardiac Surgeries
NCT07406555 DEX-CRP 146/KEPK/PE/XII/2025 Ph 4 completed Comparison of C-Reactive Protein Levels in Traumatic Brain Injury Patients Undergoing Craniotomy With and Without Dexmedetomidine
NCT06878703 DEXPRE APHP230813 Ph 3 recruiting Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants
NCT07392177 LOCUSleep 19522 Ph 2 not yet recruiting Understanding the Role of the Locus Coeruleus in Insomnia
NCT07389096 IRB00012098- Serial0307600 Ph 4 recruiting Opioid-Free Anesthesia Versus Opioid Based Anesthesia For Adolescent Idiopathic Scoliosis
NCT05439005 OFOBA IC 2021-07 Ph 3 recruiting Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
NCT07332572 LNH Ph 4 completed COMPARISON OF INTRAVENOUS DEXMEDETOMEDINE AND TRAMADOL FOR POST OPERATIVE SHIVERING AFTER SPINAL ANESTHESIA FOR CAESAREAN SECTION
NCT05793060 DTH: 23001 Ph 4 recruiting Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Intermediate Cervical Plexus Block
NCT07330375 1088 Ph 3 not yet recruiting Effect of Intravenous Dexmedetomidine and Ketamine on Post-Operative Analgesia
NCT07326397 Intrathecal Mgso4& Dex. In DHS Ph 3 not yet recruiting Comparison Between Intrathecal Magnesium Sulphate & Dexmedetomidine in DHS
NCT06418308 STUDY-23-01613 Ph 4 recruiting Intrathecal Dexmedetomidine vs Epinephrine
NCT06575530 IIT2024-001-002 Ph 4 recruiting Sedation Efficacy and Safety of Remazolam Besylate in Ventilated Surgical Critically Ill Patients
NCT04928300 17300614 Ph 3 recruiting Low Dose Dexmedetomidine Versus Normal Saline in Multiple Fracture Ribs

Showing 50 of 487 trials

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

IGALMI FDA Label Details

Indications & Usage

FDA Label (PDF)

IGALMI is indicated for the treatment of Agitation; Schizophrenia; Bipolar Disorder.

View full patent landscape →
14 OB patents · 4 families · 137 international docs across 20 countries

IGALMI Patents & Exclusivity

Latest Patent: Jan 2043
Exclusivity: Nov 2028

Patents (14 active)

US12364683 Expires Jan 12, 2043
US11998528 Expires Jan 12, 2043
US11806334 Expires Jan 12, 2043
US12090140 Expires Jan 12, 2043
US12138247 Expires Jan 12, 2043
US11998529 Expires Jul 17, 2040
US12109196 Expires Jul 17, 2040
US11890272 Expires Jul 17, 2040
US10792246 Expires Jun 26, 2039
US11517524 Expires Jun 26, 2039
US11497711 Expires Jun 26, 2039
US11478422 Expires Jun 26, 2039
US11786508 Expires Dec 29, 2037
US11839604 Expires Dec 29, 2037

Exclusivity

M-82 Until Nov 2028
M-82 Until Nov 2028
M-82 Until Nov 2028
M-82 Until Nov 2028
Source: FDA Orange Book

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Deep insights for IGALMI

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2043
  • • 60 active patents

Trial Analysis

  • • 498 total trials
  • • Stage: Mature

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA215390 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment