Data updated: May 26, 2026
DEXAMETHASONE INTENSOL (dexamethasone)
Corticosteroid Hormone Receptor Agonists
Respiratory
Approved 1983-09-01
Dexamethasone Intensol is a potent synthetic glucocorticoid indicated for the management of severe or incapacitating conditions across a broad range of therapeutic areas. Key indications include allergic states (e.g., asthma, Stevens-Johnson syndrome), endocrine disorders (e.g., adrenocortical insufficiency, hypercalcemia of malignancy), and gastrointestinal diseases (e.g., ulcerative colitis). It is also utilized for the palliative management of neoplastic diseases (leukemias and lymphomas), nervous system conditions (e.g., cerebral edema, acute exacerbations of multiple sclerosis), hematologic disorders (e.g., ITP, hemolytic anemia), and various ophthalmic, renal, and respiratory diseases.
Source: FDA Label • Hikma • Corticosteroid
How DEXAMETHASONE INTENSOL Works
Dexamethasone is a long-acting glucocorticoid that exerts its effects by binding to intracellular glucocorticoid receptors. Once bound, the receptor-ligand complex translocates to the cell nucleus, where it binds to specific DNA sequences (glucocorticoid response elements) to modulate gene transcription. This results in the up-regulation of anti-inflammatory proteins and the down-regulation of pro-inflammatory mediators, such as cytokines (IL-1, IL-6, TNF-alpha) and enzymes (COX-2). Its systemic effects include the suppression of leukocyte infiltration at inflammation sites, reduction of capillary permeability, and inhibition of the humoral and cell-mediated immune responses. Dexamethasone possesses minimal mineralocorticoid activity compared to natural cortisol.
Source: FDA Label
1
Indication
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Phase 3 Trials
42
Years on Market
Details
- Status
- Prescription
- First Approved
- 1983-09-01
- PDUFA Date
- 2026-08-17 (83d)
- Routes
- ORAL
- Dosage Forms
- CONCENTRATE
DEXAMETHASONE INTENSOL Approval History
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Original
New Indication
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Label Update
22 FDA actions from 1983 to 2024
Jun 2024 SUPPL
Label · Labeling
Jan 2024 SUPPL
Mfg · Manufacturing (CMC)
Jul 2005 SUPPL
Label · Labeling
Jan 2001 SUPPL
Mfg
Aug 1996 SUPPL
Mfg
Nov 1995 SUPPL
Label
Feb 1995 SUPPL
Label
Jul 1994 SUPPL
Mfg
Feb 1994 SUPPL
Label
Aug 1991 SUPPL
Label
Dec 1990 SUPPL
Label
Apr 1990 SUPPL
Label
Mar 1989 SUPPL
Mfg
Jan 1989 SUPPL
Update
Nov 1985 SUPPL
Mfg
May 1985 SUPPL
Mfg
Feb 1984 SUPPL
Mfg
Sep 1983 ORIGINAL
Update
What DEXAMETHASONE INTENSOL Treats
10 indicationsDEXAMETHASONE INTENSOL is approved for 10 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Atopic Dermatitis
- Contact Dermatitis
- Drug Hypersensitivity
- Allergic Rhinitis
- Serum Sickness
- Dermatitis Herpetiformis
- Exfoliative Erythroderma
Source: FDA Label
DEXAMETHASONE INTENSOL Competitive Set
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Clinical Trial Registry
1308 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04530565 | NCI-2020-06381 NCI-2020-06381, EA9181 | Ph 3 | active not recruiting | Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults |
| NCT06615479 | CA088-1007 | Ph 3 | recruiting | A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2) |
| NCT07387926 | CABL001L12101 2025-522019-40 | Ph 1, Ph 2 | not yet recruiting | Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL) |
| NCT06169215 | NCI-2023-07073 NCI-2023-07073, 10612 | Ph 2 | active not recruiting | Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma |
| NCT04847453 | NCI-2021-03038 NCI-2021-03038, PHI-124 | Ph 1 | active not recruiting | Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for the Treatment of Relapsed or Refractory Light Chain Amyloidosis |
| NCT05497804 | MC210811 P50CA186781, 22-002687 | Ph 2 | active not recruiting | Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial |
| NCT07095452 | M25-586 2025-520897-21, 2025-520897-21-00 | Ph 2, Ph 3 | recruiting | A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant |
| NCT06948084 | NCI-2025-02986 NCI-2025-02986, EAA232 | Ph 2 | not yet recruiting | Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse |
| NCT05981209 | OSU-22207 NCI-2023-05518 | Ph 1 | active not recruiting | Elotuzumab, CC-92480, and Dexamethasone for the Treatment of Relapsed or Refractory Myeloma After CD38- and BCMA-Targeted Therapies |
| NCT07463807 | NCI-2026-01300 NCI-2026-01300, EAA242 | Ph 1, Ph 2 | not yet recruiting | Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment |
| NCT03808610 | 2016-0629 NCI-2018-03360, 2016-0629 | Ph 1, Ph 2 | terminated | Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia |
| NCT05514990 | 16M-22-1 NCI-2022-06505, 16M-22-1 | Ph 1, Ph 2 | active not recruiting | Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial |
| NCT03798678 | NCI-2019-00111 NCI-2019-00111, 10219 | Ph 1 | terminated | CB-839 HCl in Combination With Carfilzomib and Dexamethasone in Treating Patients With Recurrent or Refractory Multiple Myeloma |
| NCT07444710 | NCI-2026-01137 NCI-2026-01137, PHI-158 | Ph 1 | not yet recruiting | Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma |
| NCT06317662 | NCI-2024-01994 NCI-2024-01994, AALL2321 | Ph 2 | recruiting | Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia |
| NCT07570173 | 1045-005 MK-1045-005, 2025-522267-15-00 | Ph 2, Ph 3 | recruiting | A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005) |
| NCT05638087 | 1000079288 | Ph 3 | completed | Dexamethasone Treatment for OSA in Children |
| NCT06635629 | 10001822 001822-DK | Ph 2 | recruiting | Desmopressin Stimulation Test Performance in ACTH-Dependent Cushing Syndrome |
| NCT06182774 | MY13 | Ph 3 | recruiting | Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma |
| NCT06136650 | 5684-004 MK-5684-004, jRCT2031240030 | Ph 3 | recruiting | A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) |
| NCT06152575 | C1071032 MAGNETISMM-32, 2023-507871-23-00 | Ph 3 | recruiting | MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide) |
| NCT05669989 | LTS17704 U1111-1277-6635, 2023-507180-19 | Ph 2 | active not recruiting | International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab |
| NCT05688475 | CA092-1000 2022-501855-97, U1111-1282-2472 | Ph 1 | active not recruiting | A Rollover Study of CC-122 |
| NCT05060627 | GEM-BELMA 2021-002125-15 | Ph 1, Ph 2 | active not recruiting | Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patients, Refractory to Lenalidomide |
| NCT06230224 OLYMPIA-4 | R1979-HM-2299 2022-502783-21-00 | Ph 3 | active not recruiting | A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma |
| NCT04973605 | BGB-11417-105 2023-507751-30-00, 2021-003614-39 | Ph 1, Ph 2 | recruiting | A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma |
| NCT04181827 CARTITUDE-4 results posted | CR108695 68284528MMY3002, 2019-001413-16 | Ph 3 | active not recruiting | A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma |
| NCT00871013 | 108053 | Ph 2 | active not recruiting | Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy |
| NCT05083169 MajesTEC-3 | CR109049 64007957MMY3001, 2020-004742-11 | Ph 3 | active not recruiting | A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT04923893 CARTITUDE-5 | CR109015 68284528MMY3004, 2021-001242-35 | Ph 3 | active not recruiting | A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy |
| NCT05527340 | GEM-IBERDARAX 2021-002190-25 | Ph 2 | active not recruiting | Iberdomide-dexamethasone Alone or in Combination With Standard MM Treatment Regimens in Transplant Ineligible Newly Diagnosed Patients. |
| NCT07222761 LINKER-MM5 | R5458-ONC-2246 2024-519504-27-00 | Ph 3 | recruiting | A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM) |
| NCT03150693 | A041501 NCI-2016-01981, U10CA180821 | Ph 3 | recruiting | Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia |
| NCT06577025 aMMbition | 54767414MMY2093 54767414MMY2093, 2023-505792-71-00 | Ph 2 | active not recruiting | A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma |
| NCT05438043 | CR109200 54767414MMY3030, 2021-006494-33 | Ph 3 | recruiting | A Study of Daratumumab |
| NCT05552222 MajesTEC-7 | CR109237 64007957MMY3005, 2022-000909-28 | Ph 3 | recruiting | A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma |
| NCT07576660 DEFEND | DEFEND Trial | Ph 3 | not yet recruiting | Dexamethasone Treatment for Sepsis-associated Acute Respiratory Distress Syndrome: a Multicenter, Randomised, Double-blinded, Controlled Trial |
| NCT06413498 iMMagine-3 | KT-US-679-0788 2024-511188-26, jRCT2043240170 | Ph 3 | recruiting | A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma |
| NCT07084441 COMBO | STUDY00020975 | Ph 4 | recruiting | Comparison of Outcomes of Management of Bowel Obstruction |
| NCT06106945 | D7230C00001 2023-508590-89-00 | Ph 1, Ph 2 | recruiting | AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma |
| NCT04126200 DREAMM 5 results posted | 208887 2023-509550-55-00 | Ph 1, Ph 2 | active not recruiting | Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) |
| NCT06022939 | S2213 NCI-2023-04234, S2213 | Ph 3 | recruiting | Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis |
| NCT06930651 | 2024-1967 NCI-2025-02697 | Ph 1, Ph 2 | recruiting | A Phase I/II Study of CAR.70-Engineered IL15-Transduced Cord Blood-Derived NK Cells With TGF-beta Receptor 2 (TGFBR2) Knock Out in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Myeloid Malignancies |
| NCT04043494 LBL 2018 | UKM17_0023 2017-001691-39 | Ph 3 | recruiting | International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma |
| NCT06437054 | ITV-2309-098-1469 | Ph 1, Ph 2 | not yet recruiting | Verification of the Efficacy/Safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss |
| NCT04566328 | EAA181 NCI-2020-06647, EAA181 | Ph 3 | recruiting | Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial |
| NCT06136624 OMAHA-003 | 5684-003 2023-504899-25-00, MK-5684-003 | Ph 3 | recruiting | Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) |
| NCT06616584 | S1800E NCI-2024-06444, S1800E | Ph 2, Ph 3 | recruiting | Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial) |
| NCT03556332 | 17-493 | Ph 2 | active not recruiting | A Study of Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab for Patients With Relapsed/Refractory Myeloma With Salvage Autologous Hematopoietic Cell Transplantation |
| NCT03937635 | EAA173 NCI-2018-02611, EAA173 | Ph 3 | recruiting | Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma |
Showing 50 of 1308 trials
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Trial Timeline
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.
DEXAMETHASONE INTENSOL FDA Label Details
Indications & Usage
DEXAMETHASONE INTENSOL is indicated for the treatment of Asthma; Atopic Dermatitis; Contact Dermatitis; Drug Hypersensitivity; Allergic Rhinitis; Serum Sickness; Dermatitis Herpetiformis; Exfoliative Erythroderma; Mycosis Fungoides; Pemphigus.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.