Last reviewed 2026-06-02 · How we verify

Clindamycin+Dexamethasone

Shahid Beheshti University of Medical Sciences · Phase 3 active Small molecule Under review Quality 0/100

Clindamycin+Dexamethasone is a Antibiotic + Corticosteroid combination Small molecule drug developed by Shahid Beheshti University of Medical Sciences. It is currently in Phase 3 development for Severe bacterial infections with significant inflammatory component (Phase 3 investigational).

Clindamycin inhibits bacterial protein synthesis while dexamethasone suppresses inflammation and immune response, combining antimicrobial and anti-inflammatory effects.

Clindamycin is a small molecule that inhibits the bacterial 70S ribosome, classified as an inhibitor. It is used in combination with dexamethasone for various conditions, including cerebral toxoplasmosis, as seen in clinical trials such as NCT04341155.

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	Clindamycin+Dexamethasone
Sponsor	Shahid Beheshti University of Medical Sciences
Drug class	Antibiotic + Corticosteroid combination
Target	Bacterial 50S ribosome (clindamycin); Glucocorticoid receptor (dexamethasone)
Modality	Small molecule
Therapeutic area	Infectious Disease / Immunology
Phase	Phase 3

Mechanism of action

Clindamycin is a lincosamide antibiotic that binds to bacterial 50S ribosomal subunits to inhibit protein synthesis, effective against anaerobic and gram-positive organisms. Dexamethasone is a potent corticosteroid that reduces inflammation by suppressing immune cell activation and cytokine production. The combination targets both infection and inflammatory complications.

Approved indications

Severe bacterial infections with significant inflammatory component (Phase 3 investigational)

Common side effects

Diarrhea (clindamycin-associated)
Pseudomembranous colitis
Hyperglycemia (dexamethasone)
Immunosuppression
Insomnia

Key clinical trials

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:

Clindamycin+Dexamethasone CI brief — competitive landscape report
Clindamycin+Dexamethasone updates RSS · CI watch RSS
Shahid Beheshti University of Medical Sciences portfolio CI

Frequently asked questions about Clindamycin+Dexamethasone

What is Clindamycin+Dexamethasone?

Clindamycin+Dexamethasone is a Antibiotic + Corticosteroid combination drug developed by Shahid Beheshti University of Medical Sciences, indicated for Severe bacterial infections with significant inflammatory component (Phase 3 investigational).

How does Clindamycin+Dexamethasone work?

Clindamycin inhibits bacterial protein synthesis while dexamethasone suppresses inflammation and immune response, combining antimicrobial and anti-inflammatory effects.

What is Clindamycin+Dexamethasone used for?

Clindamycin+Dexamethasone is indicated for Severe bacterial infections with significant inflammatory component (Phase 3 investigational).

Who makes Clindamycin+Dexamethasone?

Clindamycin+Dexamethasone is developed by Shahid Beheshti University of Medical Sciences (see full Shahid Beheshti University of Medical Sciences pipeline at /company/shahid-beheshti-university-of-medical-sciences).

What drug class is Clindamycin+Dexamethasone in?

Clindamycin+Dexamethasone belongs to the Antibiotic + Corticosteroid combination class. See all Antibiotic + Corticosteroid combination drugs at /class/antibiotic-corticosteroid-combination.

What development phase is Clindamycin+Dexamethasone in?

Clindamycin+Dexamethasone is in Phase 3.

What are the side effects of Clindamycin+Dexamethasone?

Common side effects of Clindamycin+Dexamethasone include Diarrhea (clindamycin-associated), Pseudomembranous colitis, Hyperglycemia (dexamethasone), Immunosuppression, Insomnia.

What does Clindamycin+Dexamethasone target?

Clindamycin+Dexamethasone targets Bacterial 50S ribosome (clindamycin); Glucocorticoid receptor (dexamethasone) and is a Antibiotic + Corticosteroid combination.

Drug class: All Antibiotic + Corticosteroid combination drugs
Target: All drugs targeting Bacterial 50S ribosome (clindamycin); Glucocorticoid receptor (dexamethasone)
Manufacturer: Shahid Beheshti University of Medical Sciences — full pipeline
Therapeutic area: All drugs in Infectious Disease / Immunology
Indication: Drugs for Severe bacterial infections with significant inflammatory component (Phase 3 investigational)

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