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šŸ’Š drug-pipeline-mcp

CI Tests Docker Smithery Python 3.10+ License: MIT PyPI GitHub stars

Pharmaceutical R&D Pipeline Intelligence for AI Agents — a lightweight MCP server that aggregates clinical trial data, FDA/EMA approvals, safety surveillance (FAERS), drug labels, patents, drug interactions, recalls, and publications through a unified API. Every output includes a verifiable source identifier (NCT ID, FDA Application Number, or PMID).

Not a replacement for IQVIA/EvaluatePharma. A real-time, publicly accessible intelligence layer that complements subscription databases.


Quick Start

pip install git+https://github.com/DasClown/drug-pipeline-mcp.git

# Start MCP server (stdio)
drug-pipeline

# Or HTTP mode for remote access
pip install drug-pipeline-mcp[http]
drug-pipeline --http --port 8081

Or deploy via Smithery — one click, no config.


Related MCP server: aria-mcp-server

Tools (28)

Tool

What it does

Data Source

search_trials

Search clinical trials by condition, phase, status, sponsor

ClinicalTrials.gov

get_trial_detail

Full protocol for a specific NCT (eligibility, outcomes, locations)

ClinicalTrials.gov

get_trial_results

Trial outcomes — endpoints, adverse events, participant flow

ClinicalTrials.gov

get_trial_sites

Trial site locations — facilities, countries, geo distribution

ClinicalTrials.gov

lookup_drug

Drug info: active ingredients, strength, ATC classification, NDC

openFDA + RxNorm

get_approvals

FDA approval history with submission dates and status

openFDA Drugs@FDA

get_eu_approvals

EU/EMA authorization — brand names, ATC, status, orphan/biosimilar flags

EMA Daily XLSX

get_safety_data

FAERS adverse event reports — top reactions, serious outcomes, total count

openFDA FAERS

detect_safety_signals

Disproportionality screening (exploratory) — AE reporting ratios

openFDA FAERS

get_drug_label

FDA prescribing info — indications, boxed warnings, contraindications, dosing

openFDA Drug Labeling

get_dailymed_label

NIH drug label (OTC + Rx) — SPL set ID, version, DailyMed URL

DailyMed (NIH/NLM)

get_recalls

FDA drug recalls — Class I/II/III, reasons, dates, firms

openFDA Enforcement

get_patent_expiry

Patent & exclusivity — approval dates, market exclusivity estimates

openFDA

get_drug_interactions

Drug-drug interactions — FDA label + FAERS co-reported drugs

openFDA Labeling + FAERS

get_drug_pricing

US drug product ID — NDC codes, manufacturers, strength, form

openFDA NDC Directory

get_opentargets_drug

Drug-target MOA — mechanisms, targets, clinical stage, drug type

Open Targets (EMBL-EBI)

get_us_orphan_designations

US FDA Orphan Drug Designations — indication, status, exclusivity

MyChem.info

approved_for_condition

Find drugs by indication — which are EU-approved for a condition

EMA Daily XLSX

list_orphan_drugs

EU orphan drug designations — filter by therapeutic area

EMA Daily XLSX

list_biosimilars

EU biosimilars — filter by condition / therapeutic area

EMA Daily XLSX

list_loss_of_exclusivity

LOE timing — biosimilar competition by active substance

EMA + FDA

company_pipeline

Company R&D — trials grouped by phase + EU approval enrichment

ClinicalTrials.gov + EMA

search_publications

PubMed search for drug/trial publications

PubMed / NCBI

find_investigators

KOL / PI search — investigators by condition or drug

ClinicalTrials.gov + PubMed

detect_combination_therapies

Combination therapy detection — co-administered drugs in trials

ClinicalTrials.gov

compare_drugs

Head-to-head — FDA, EU, MOA, safety, patent across 2 drugs

Composite

drug_pipeline

Composite — drug info + FDA + EU + safety + label + signals + recalls + interactions + trials + pubs + patent

All sources

pipeline_landscape

Full pipeline for a condition — approved + Phase 3/2/1 + mechanisms + sponsors + pubs

Composite

āš ļø detect_safety_signals: Exploratory disproportionality screening — uses an approximate denominator, not a validated PRR. Not for regulatory or clinical use. See methodology note in code.


Architecture

drug-pipeline-mcp/
ā”œā”€ā”€ drug_pipeline/
│   ā”œā”€ā”€ __init__.py        # Version
│   ā”œā”€ā”€ server.py          # MCP server (28 tools)
│   └── sources.py         # Data source fetchers (API aggregation layer)
ā”œā”€ā”€ drug_pipeline_cli.py   # CLI entry point
ā”œā”€ā”€ tests/                 # 61 unit tests (pytest)
ā”œā”€ā”€ pyproject.toml
└── README.md

Design philosophy: Lightweight API aggregation. No caching layer. No ML models. No predictions. Each tool makes real-time requests to a public API and returns structured data with source identifiers. The server is intentionally simple — it extracts, structures, and annotates, nothing more.

Limitations by design:

  • Rate limits apply per source (openFDA: 10 req/sec, ClinicalTrials.gov: generous)

  • EMA data sourced from a daily-updated XLSX register — format changes monitored manually

  • FAERS data is spontaneous reporting, not incidence rates

  • The server does not interpret, predict, or synthesize beyond what the sources provide


Data Sources

Source

Data

Access

ClinicalTrials.gov

500K+ studies, phases, status, eligibility, results, site locations

āœ… Always free

openFDA NDC Directory

Drug product ID, NDC codes, manufacturers

āœ… Always free

openFDA FAERS

Adverse event reports, reactions, serious outcomes

āœ… Always free

openFDA Drug Labeling

Prescribing info, interactions, contraindications

āœ… Always free

openFDA Drugs@FDA

Approval history, submissions, orphan designations

āœ… Always free

openFDA Enforcement

Recalls, market withdrawals, safety alerts

āœ… Always free

RxNorm / RxNav

Drug identifiers, RxCUI, ATC classification

āœ… Always free

PubMed / NCBI

Scientific publications, abstracts, PMIDs

āœ… Always free

EMA Medicines Register

EU authorization status, ATC, orphan/biosimilar flags

āœ… Always free

Open Targets (EMBL-EBI)

Drug-target mechanisms of action, clinical development stage

āœ… Always free

DailyMed (NIH/NLM)

Drug labels (OTC + Rx), structured product labeling

āœ… Always free

MyChem.info

US FDA Orphan Drug Designations

āœ… Always free

All sources are publicly funded and freely accessible. No API keys, subscriptions, or licensing required.


Verifiable Outputs

Every data point includes a direct link to its primary source:

Output Field

Example Source URL

NCT ID

https://clinicaltrials.gov/study/NCT03178617

FDA Application Number

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA125456

PMID

https://pubmed.ncbi.nlm.nih.gov/37272535/

FDA Product NDC

https://www.accessdata.fda.gov/scripts/cder/ndc/

DailyMed SPL Set ID

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=xxx

No calculated fields. No predictions. No estimates. The tool is an aggregator, not an oracle — it brings primary-source data into an AI agent's context so the LLM can apply reasoning, not so the server can produce answers.


Testing & Quality

Check

Status

Unit tests

āœ… 61 passing (pytest)

CI/CD

āœ… Multi-Python matrix (3.10–3.13), Docker build, PyPI publish

Linting

āœ… Ruff (zero warnings)

Formatting

āœ… Black-compatible

Code coverage

Tracked in CI


Regulatory Intelligence

Beyond drug-level approvals, this project provides multi-jurisdiction regulatory framework intelligence for pipeline analysis. See docs/local-regulation-2026.md for a comprehensive reference covering 7 jurisdictions:

  • šŸ‡ŗšŸ‡ø US IRA — Medicare Part D price negotiation (Sep 2026), Small Molecule Penalty (7 yr vs 13 yr)

  • šŸ‡©šŸ‡Ŗ Germany AMNOG — Benefit assessment, 2026 reform with fixed effect-size thresholds

  • šŸ‡«šŸ‡· France HAS/CEPS — SMR/ASMR ratings, 400–600 day access timelines

  • šŸ‡®šŸ‡¹ Italy AIFA — 21 regional formularies, payback mechanisms

  • šŸ‡¬šŸ‡§ UK MHRA/NICE — Post-Brexit ILAP pathway, Ā£/QALY thresholds

  • šŸ‡ÆšŸ‡µ Japan PMDA/NHI — Sakigake designation, biennial price revision

  • šŸ‡ØšŸ‡³ China NMPA/NRDL — Annual –61% price negotiation


Example Agent Queries

"What's in the pipeline for GLP-1 agonists?" → drug_pipeline(drug_name="semaglutide") → ATC class, FDA status, clinical trials, publications

"Which companies have Phase 3 trials for non-small cell lung cancer?" → search_trials(condition="non-small cell lung cancer", phase="PHASE3", status="RECRUITING")

"Is pembrolizumab approved in the EU vs US?" → get_approvals(drug_name="Keytruda") + get_eu_approvals(drug_name="Keytruda")

"What are the safety signals for semaglutide?" → get_safety_data(drug_name="semaglutide") + detect_safety_signals(drug_name="semaglutide")

"What does the label say for Keytruda?" → get_drug_label(drug_name="Keytruda") → indications, boxed warnings, contraindications, dosing

"When does the patent for Keytruda expire?" → get_patent_expiry(drug_name="Keytruda") → exclusivity information

"What drugs are approved for non-small cell lung cancer in the EU?" → approved_for_condition(condition="non-small cell lung cancer")


Client Integration

Claude Desktop

{
  "mcpServers": {
    "drug-pipeline": {
      "command": "python3",
      "args": ["-m", "drug_pipeline.server"]
    }
  }
}

Cursor / VS Code

{
  "mcpServers": {
    "drug-pipeline": {
      "command": "uvx",
      "args": ["drug-pipeline-mcp"]
    }
  }
}

HTTP / SSE (Remote)

pip install drug-pipeline-mcp[http]
drug-pipeline --http --port 8081

Connect at http://your-server:8081/sse.

Smithery

One-click deploy. No config needed.


šŸ¤ Getting Help & Contributing

Channel

Purpose

šŸ’¬ GitHub Discussions

Questions before coding, feature ideas, community chat

šŸ› GitHub Issues

Bug reports, confirmed feature requests

šŸ“– CONTRIBUTING.md

Development setup, code style, testing

New contributors welcome. See CONTRIBUTING.md for setup instructions.


License

MIT

A
license - permissive license
-
quality - not tested
A
maintenance

Maintenance

–Maintainers
–Response time
2wRelease cycle
2Releases (12mo)
Commit activity

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