Last reviewed 2026-04-23 · How we verify

Grup 2 dexametasona

Instituto de Investigación Sanitaria y Biomédica de Alicante · Phase 3 active Small molecule

Grup 2 dexametasona is a Glucocorticoid Small molecule drug developed by Instituto de Investigación Sanitaria y Biomédica de Alicante. It is currently in Phase 3 development for Inflammatory and autoimmune conditions (specific indication for this Phase 3 trial unknown).

Dexamethasone is a synthetic glucocorticoid that suppresses the immune system and reduces inflammation by binding to glucocorticoid receptors.

Dexamethasone is a synthetic glucocorticoid that suppresses the immune system and reduces inflammation by binding to glucocorticoid receptors. Used for Inflammatory and autoimmune conditions (specific indication for this Phase 3 trial unknown).

Likelihood of approval

59.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Grup 2 dexametasona
Sponsor	Instituto de Investigación Sanitaria y Biomédica de Alicante
Drug class	Glucocorticoid
Target	Glucocorticoid receptor
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 3

Mechanism of action

Dexamethasone acts as a potent corticosteroid that inhibits pro-inflammatory cytokine production, reduces immune cell activation and migration, and suppresses both cellular and humoral immune responses. It is commonly used to manage inflammatory and autoimmune conditions by broadly dampening immune and inflammatory pathways.

Approved indications

Inflammatory and autoimmune conditions (specific indication for this Phase 3 trial unknown)

Common side effects

Hyperglycemia
Hypertension
Insomnia
Mood changes
Immunosuppression
Osteoporosis (with chronic use)

Key clinical trials

Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Grup 2 dexametasona CI brief — competitive landscape report
Grup 2 dexametasona updates RSS · CI watch RSS
Instituto de Investigación Sanitaria y Biomédica de Alicante portfolio CI

Frequently asked questions about Grup 2 dexametasona

What is Grup 2 dexametasona?

Grup 2 dexametasona is a Glucocorticoid drug developed by Instituto de Investigación Sanitaria y Biomédica de Alicante, indicated for Inflammatory and autoimmune conditions (specific indication for this Phase 3 trial unknown).

How does Grup 2 dexametasona work?

Dexamethasone is a synthetic glucocorticoid that suppresses the immune system and reduces inflammation by binding to glucocorticoid receptors.

What is Grup 2 dexametasona used for?

Grup 2 dexametasona is indicated for Inflammatory and autoimmune conditions (specific indication for this Phase 3 trial unknown).

Who makes Grup 2 dexametasona?

Grup 2 dexametasona is developed by Instituto de Investigación Sanitaria y Biomédica de Alicante (see full Instituto de Investigación Sanitaria y Biomédica de Alicante pipeline at /company/instituto-de-investigaci-n-sanitaria-y-biom-dica-de-alicante).

What drug class is Grup 2 dexametasona in?

Grup 2 dexametasona belongs to the Glucocorticoid class. See all Glucocorticoid drugs at /class/glucocorticoid.

What development phase is Grup 2 dexametasona in?

Grup 2 dexametasona is in Phase 3.

What are the side effects of Grup 2 dexametasona?

Common side effects of Grup 2 dexametasona include Hyperglycemia, Hypertension, Insomnia, Mood changes, Immunosuppression, Osteoporosis (with chronic use).

What does Grup 2 dexametasona target?

Grup 2 dexametasona targets Glucocorticoid receptor and is a Glucocorticoid.

Drug class: All Glucocorticoid drugs
Target: All drugs targeting Glucocorticoid receptor
Manufacturer: Instituto de Investigación Sanitaria y Biomédica de Alicante — full pipeline
Therapeutic area: All drugs in Immunology
Indication: Drugs for Inflammatory and autoimmune conditions (specific indication for this Phase 3 trial unknown)

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing