TheraRadar
Data updated: May 26, 2026

DEXAMETHASONE

Corticosteroid Hormone Receptor Agonists
Respiratory Approved 1971-10-20

Dexamethasone is a potent synthetic glucocorticoid indicated for the management of a wide range of severe or incapacitating allergic, inflammatory, and neoplastic conditions. It is utilized across multiple specialties for patients with respiratory, dermatologic, gastrointestinal, ophthalmic, and renal diseases that are unresponsive to conventional treatments. Key indications include the control of severe allergic states (e.g., asthma, Stevens-Johnson syndrome), endocrine disorders (e.g., adrenal insufficiency, congenital adrenal hyperplasia), and the reduction of cerebral edema associated with malignancy or head injury. Additionally, it is employed in the palliative management of certain leukemias and lymphomas, the treatment of acquired hemolytic anemia, and as a diagnostic tool for adrenocortical hyperfunction.

Source: FDA Label • Sun Pharma • Corticosteroid
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How DEXAMETHASONE Works

Dexamethasone is a long-acting corticosteroid with primary glucocorticoid activity and minimal mineralocorticoid effects. It diffuses across cell membranes and binds to specific cytoplasmic glucocorticoid receptors. This receptor-ligand complex translocates to the nucleus, where it binds to glucocorticoid response elements (GREs) to modulate gene expression. It promotes the synthesis of anti-inflammatory proteins (such as lipocortins, which inhibit phospholipase A2) and suppresses the transcription of pro-inflammatory genes (including cytokines, interleukins, and adhesion molecules) by inhibiting transcription factors like NF-κB and AP-1. These actions result in reduced capillary permeability, decreased leukocyte migration, and overall suppression of the immune and inflammatory response.

Source: FDA Label
34
Indications
--
Phase 3 Trials
54
Years on Market

Details

Status
Discontinued
First Approved
1971-10-20
PDUFA Date
2026-08-17 (83d)
Routes
ORAL, INJECTION, OPHTHALMIC
Dosage Forms
TABLET, ELIXIR, INJECTABLE, SOLUTION, SUSPENSION/DROPS

Companies

Sun Pharma CHARTWELL RX Apotex WATSON LABS COREPHARMA KANCHAN HLTHCARE IMPAX LABS UPSHER SMITH ABRAXIS PHARM NOVITIUM PHARMA BIONPHARMA PHOENIX LABS NY WHITEWORTH TOWN PLSN ROXANE KEY THERAP RISING AMNEAL ZYDUS LIFESCIENCES Hikma PHARMOBEDIENT CNSLTG Fresenius Kabi PVT FORM PHARMOBEDIENT PRASCO PANGEA ALVOGEN ALPHARMA US PHARMS BAUSCH CHARTWELL MOLECULAR
Active Ingredient: DEXAMETHASONE

DEXAMETHASONE Approval History

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Original
New Indication
New Form
Label Update
575 FDA actions from 1971 to 2024
Sep 2024 ORIGINAL
Update
Jul 2024 SUPPL
Label · Labeling
Jun 2024 SUPPL
Label · Labeling

What DEXAMETHASONE Treats

10 indications

DEXAMETHASONE is approved for 10 conditions since its original approval in 1971. 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 Competitive Set

Pro

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

Indication competitors

10

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

EXDENSUR
GSK
2025 1 indic.
OMLYCLO
CELLTRION INC
2025 6 indic.
Unlock 8 more competitors across all three rings.
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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.

What's emerging in DEXAMETHASONE's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DEXAMETHASONE treats. First-in-class if their pivotal trials read out positive.

Rocatinlimab AMG 451 / KHK4083 ✓ Won — Ph3 readout
Amgen
TNFRSF4 · monoclonal antibody (anti-OX40, depleting) · 8 Phase 3 trials
Afimkibart RVT-3101 / PRA023
Hoffmann-La Roche
TNFSF15 · monoclonal antibody (anti-TL1A) · 6 Phase 3 trials

Drugs Similar to DEXAMETHASONE

3 of 20

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

DEXAMETHASONE INTENSOL
DEXAMETHASONE
10 shared
Hikma
Shared indications:
AsthmaAtopic DermatitisContact Dermatitis +7 more
DEXYCU KIT
DEXAMETHASONE
10 shared
EYEPOINT PHARMS
Shared indications:
AsthmaAtopic DermatitisContact Dermatitis +7 more
CELESTONE SOLUSPAN
BETAMETHASONE ACETATE
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Merck
Shared indications:
AsthmaAtopic DermatitisContact Dermatitis +6 more
View all 20 similar drugs Pro
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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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Active Pipeline

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Ongoing clinical trials by development phase

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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.

DEXAMETHASONE FDA Label Details

Indications & Usage

DEXAMETHASONE 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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DEXTENZA

Full clinical data, patents, trials, and competitive landscape for dexamethasone.

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Data Sources

FDA Approval: ANDA084084 → Label: DailyMed → Trials: ClinicalTrials.gov →

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