Last reviewed 2026-06-01 · How we verify

Clarithromycin DST (125 mg)

Grünenthal GmbH · Phase 3 active Small molecule Under review

Clarithromycin DST (125 mg) is a Macrolide antibiotic Small molecule drug developed by Grünenthal GmbH. It is currently in Phase 3 development for Bacterial respiratory tract infections, Helicobacter pylori eradication (as part of combination therapy), Atypical pneumonia (Mycoplasma, Chlamydia).

Clarithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit.

Clarithromycin DST (125 mg) is a small molecule used to treat various upper respiratory tract infections, including Otitis Media, Tonsillitis, Pharyngitis, and Bronchitis. It is administered in a novel application form, specifically designed for children, to improve treatment satisfaction and adherence.

Likelihood of approval

60.3% 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).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

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	Clarithromycin DST (125 mg)
Sponsor	Grünenthal GmbH
Drug class	Macrolide antibiotic
Target	Bacterial 50S ribosomal subunit
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 3

Mechanism of action

Clarithromycin binds irreversibly to the bacterial 50S ribosomal subunit, blocking peptide translocation and inhibiting protein synthesis. This bacteriostatic action prevents bacterial growth and replication. The drug is effective against a broad spectrum of gram-positive and some gram-negative bacteria, as well as atypical organisms.

Approved indications

Bacterial respiratory tract infections
Helicobacter pylori eradication (as part of combination therapy)
Atypical pneumonia (Mycoplasma, Chlamydia)

Common side effects

Gastrointestinal disturbance (nausea, diarrhea, abdominal pain)
Headache
Taste disturbance
QT prolongation
Hepatotoxicity

Key clinical trials

Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections (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:

Clarithromycin DST (125 mg) CI brief — competitive landscape report
Clarithromycin DST (125 mg) updates RSS · CI watch RSS
Grünenthal GmbH portfolio CI

Frequently asked questions about Clarithromycin DST (125 mg)

What is Clarithromycin DST (125 mg)?

Clarithromycin DST (125 mg) is a Macrolide antibiotic drug developed by Grünenthal GmbH, indicated for Bacterial respiratory tract infections, Helicobacter pylori eradication (as part of combination therapy), Atypical pneumonia (Mycoplasma, Chlamydia).

How does Clarithromycin DST (125 mg) work?

Clarithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit.

What is Clarithromycin DST (125 mg) used for?

Clarithromycin DST (125 mg) is indicated for Bacterial respiratory tract infections, Helicobacter pylori eradication (as part of combination therapy), Atypical pneumonia (Mycoplasma, Chlamydia).

Who makes Clarithromycin DST (125 mg)?

Clarithromycin DST (125 mg) is developed by Grünenthal GmbH (see full Grünenthal GmbH pipeline at /company/gr-nenthal-gmbh).

What drug class is Clarithromycin DST (125 mg) in?

Clarithromycin DST (125 mg) belongs to the Macrolide antibiotic class. See all Macrolide antibiotic drugs at /class/macrolide-antibiotic.

What development phase is Clarithromycin DST (125 mg) in?

Clarithromycin DST (125 mg) is in Phase 3.

What are the side effects of Clarithromycin DST (125 mg)?

Common side effects of Clarithromycin DST (125 mg) include Gastrointestinal disturbance (nausea, diarrhea, abdominal pain), Headache, Taste disturbance, QT prolongation, Hepatotoxicity.

What does Clarithromycin DST (125 mg) target?

Clarithromycin DST (125 mg) targets Bacterial 50S ribosomal subunit and is a Macrolide antibiotic.

Drug class: All Macrolide antibiotic drugs
Target: All drugs targeting Bacterial 50S ribosomal subunit
Manufacturer: Grünenthal GmbH — full pipeline
Therapeutic area: All drugs in Infectious Disease
Indication: Drugs for Bacterial respiratory tract infections
Indication: Drugs for Helicobacter pylori eradication (as part of combination therapy)
Indication: Drugs for Atypical pneumonia (Mycoplasma, Chlamydia)

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