Last reviewed 2026-05-28 · How we verify

Fosmidomycin and clindamycin

Zentopharm GmbH · Phase 2 active Small molecule ✓ Verified May 2026

Fosmidomycin and clindamycin is a Antibiotic Small molecule drug developed by Zentopharm GmbH. It is currently in Phase 2 development for Treatment of malaria caused by Plasmodium falciparum, Treatment of bacterial infections, including those caused by Staphylococcus aureus and Streptococcus pyogenes.

Fosmidomycin inhibits the enzyme 1-deoxy-D-xylulose-5-phosphate reductoisomerase, which is involved in the biosynthesis of isoprenoids, while clindamycin is a lincosamide antibiotic that inhibits protein synthesis by binding to the 50S ribosomal subunit.

Fosmidomycin and clindamycin are being studied in clinical trials for the treatment of acute uncomplicated Plasmodium falciparum malaria. Fosmidomycin and clindamycin are co-administered in a multicentre evaluation for this condition.

Likelihood of approval

17.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Fosmidomycin and clindamycin
Sponsor	Zentopharm GmbH
Drug class	Antibiotic
Target	1-deoxy-D-xylulose-5-phosphate reductoisomerase, 50S ribosomal subunit
Modality	Small molecule
Therapeutic area	Infectious Diseases
Phase	Phase 2

Mechanism of action

Fosmidomycin targets the 1-deoxy-D-xylulose-5-phosphate reductoisomerase enzyme, which is crucial for the production of isoprenoids. This leads to a reduction in the levels of isoprenoids, which are essential for the growth and survival of certain bacteria. Clindamycin, on the other hand, binds to the 50S ribosomal subunit, preventing the elongation of the peptide chain and ultimately inhibiting protein synthesis.

Approved indications

Treatment of malaria caused by Plasmodium falciparum
Treatment of bacterial infections, including those caused by Staphylococcus aureus and Streptococcus pyogenes

Common side effects

Nausea
Vomiting
Diarrhea
Abdominal pain

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:

Fosmidomycin and clindamycin CI brief — competitive landscape report
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Frequently asked questions about Fosmidomycin and clindamycin

What is Fosmidomycin and clindamycin?

Fosmidomycin and clindamycin is a Antibiotic drug developed by Zentopharm GmbH, indicated for Treatment of malaria caused by Plasmodium falciparum, Treatment of bacterial infections, including those caused by Staphylococcus aureus and Streptococcus pyogenes.

How does Fosmidomycin and clindamycin work?

What is Fosmidomycin and clindamycin used for?

Fosmidomycin and clindamycin is indicated for Treatment of malaria caused by Plasmodium falciparum, Treatment of bacterial infections, including those caused by Staphylococcus aureus and Streptococcus pyogenes.

Who makes Fosmidomycin and clindamycin?

Fosmidomycin and clindamycin is developed by Zentopharm GmbH (see full Zentopharm GmbH pipeline at /company/zentopharm-gmbh).

What drug class is Fosmidomycin and clindamycin in?

Fosmidomycin and clindamycin belongs to the Antibiotic class. See all Antibiotic drugs at /class/antibiotic.

What development phase is Fosmidomycin and clindamycin in?

Fosmidomycin and clindamycin is in Phase 2.

What are the side effects of Fosmidomycin and clindamycin?

Common side effects of Fosmidomycin and clindamycin include Nausea, Vomiting, Diarrhea, Abdominal pain.

What does Fosmidomycin and clindamycin target?

Fosmidomycin and clindamycin targets 1-deoxy-D-xylulose-5-phosphate reductoisomerase, 50S ribosomal subunit and is a Antibiotic.

Drug class: All Antibiotic drugs
Target: All drugs targeting 1-deoxy-D-xylulose-5-phosphate reductoisomerase, 50S ribosomal subunit
Manufacturer: Zentopharm GmbH — full pipeline
Therapeutic area: All drugs in Infectious Diseases
Indication: Drugs for Treatment of malaria caused by Plasmodium falciparum
Indication: Drugs for Treatment of bacterial infections, including those caused by Staphylococcus aureus and Streptococcus pyogenes

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