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Cergem (GEMEPROST)

Phase 2 active Small molecule

Cergem (generic name: GEMEPROST) is a gemeprost drug. It is currently in Phase 2 development.

Gemeprost works by mimicking the action of prostaglandins, a group of hormone-like substances that play a role in various bodily functions.

Cergem, also known as Gemeprost, is a small molecule drug in the gemeprost class. It is used to treat certain conditions, but its exact target and approved indications are unknown. The commercial status of Cergem is unclear, and it is not known whether it is patented or available as a generic. Further research is needed to determine its key safety considerations and pharmacological properties. As a result, Cergem is not widely recognized in the pharmaceutical industry.

Likelihood of approval
15.3% 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).
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 nameGEMEPROST
Drug classgemeprost
ModalitySmall molecule
Therapeutic areaHematology
PhasePhase 2

Mechanism of action

In simple terms, prostaglandins are like messengers that help different parts of the body communicate with each other. Gemeprost is a synthetic version of these messengers, which can help to relax muscles and improve blood flow. This can be beneficial in treating conditions where these processes are disrupted.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Cergem

What is Cergem?

Cergem (GEMEPROST) is a gemeprost drug.

How does Cergem work?

Gemeprost works by mimicking the action of prostaglandins, a group of hormone-like substances that play a role in various bodily functions.

What is the generic name of Cergem?

GEMEPROST is the generic (nonproprietary) name of Cergem.

What drug class is Cergem in?

Cergem belongs to the gemeprost class. See all gemeprost drugs at /class/gemeprost.

What development phase is Cergem in?

Cergem is in Phase 2.

Related

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