Product Description
Dexmedetomidine is a new generation highly selective a2-adrenergic receptor (a2-AR) agonist that is associated with sedative and analgesic sparing effects, reduced delirium and agitation, perioperative sympatholysis, cardiovascular stabilizing effects, and preservation of respiratory function.
Mechanisms of Action: ADRA2A Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous, Oral, Nasal
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, China, Japan, United States
Active Clinical Trial Count: 16
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Acute Respiratory Distress Syndrome|Anesthesia Related|COVID-19|Delirium|Other|Psychomotor Agitation|Stress Disorders, Post-Traumatic
Phase 2: Affective Disorders, Psychotic|Bipolar Disorder|Psychomotor Disorders|Psychotic Disorders|Schizophrenia
Phase 1: Acute Pain|Alcoholism|Healthy Volunteers
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2020-004802-70 |
PET-DEXDO COVID | P3 |
Active, not recruiting |
Acute Respiratory Distress Syndrome|COVID-19 |
2022-06-11 |
2022-03-13 |
Treatments |
|
ACTRN12616000472471 |
ACTRN12616000472471 | P1 |
Not yet recruiting |
Acute Pain |
2016-06-02 |
2024-08-29 |
Treatments |
|
NCT07168720 |
BOJI2025016LH | P2 |
Recruiting |
Other |
2026-03-30 |
2% |
2025-09-12 |
Primary Endpoints|Treatments |
NCT07116694 |
BXCL501-402 | P2 |
Active, not recruiting |
Schizophrenia|Psychomotor Agitation|Affective Disorders, Psychotic|Bipolar Disorder|Psychomotor Disorders|Psychotic Disorders |
2025-10-01 |
2% |
2025-09-16 |
Primary Endpoints |
NCT04801589 |
mini-MENDS | P3 |
Recruiting |
Delirium|Stress Disorders, Post-Traumatic |
2026-04-17 |
27% |
2024-06-11 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06335407 |
AS210006-A08 | P1 |
Recruiting |
Stress Disorders, Post-Traumatic|Alcoholism |
2026-03-30 |
50% |
2025-10-28 |
|
jRCT2031250324 |
jRCT2031250324 | P3 |
Not yet recruiting |
Psychomotor Agitation|Delirium |
2027-04-30 |
|||
jRCT2031250405 |
jRCT2031250405 | P3 |
Not yet recruiting |
Psychomotor Agitation|Delirium |
2027-03-31 |
|||
2022-001027-33 |
PAFIBAR 1.0 | P3 |
Active, not recruiting |
Unknown |
2025-06-07 |
2025-07-07 |
Treatments |
|
2018-003063-64 |
PEDRUX | P3 |
Active, not recruiting |
Other |
2019-05-28 |
2025-07-05 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
CTR20181090 |
CTR20181090 | P3 |
Recruiting |
Anesthesia Related |
None |
2025-04-29 |
Patient Enrollment|Treatments|Trial Status |
|
CTR20222363 |
CTR20222363 | P1 |
Completed |
Healthy Volunteers |
2023-12-25 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT04827056 |
AS170014-A7 | P1 |
Completed |
Stress Disorders, Post-Traumatic|Alcoholism |
2023-05-02 |
21% |
2023-10-27 |
Primary Endpoints |
ACTRN12625000103460 |
SIMDEX | P2 |
Not yet recruiting |
Delirium |
2026-04-06 |
2025-01-31 |
Treatments |
|
CTR20231653 |
CTR20231653 | P2 |
Completed |
Unknown |
2024-05-02 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
CTR20253327 |
CTR20253327 | P2 |
Recruiting |
Other |
None |
2025-09-07 |
Patient Enrollment|Treatments|Trial Status |
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