Product

Ecallantide

ATLPD0000038

Product-level evidence profile for identity, peptide link, PK exposure, clinical context, safety context, label material, and reproducible data access.

Formulation context: Injection, solution

ADMETatlas ID
ATLPD0000038
Peptide-link status
Identity status
Linked peptides
1
Route
subcutaneous
PK summaries
0
Trial references
13
Label references
0

Product evidence profile

Product identity, peptide link, PK exposure evidence, safety context, clinical and label context, interpretation boundaries, and reproducibility exits available for this product.

Profile overview

5 of 6 profile areas have current evidence, product context, or reviewed identity linkage.

AvailableNo current evidence

Linked peptides

Identity status

PK summaries

0 cited measurements

Context signals

context evidence index

Label references

regulatory context

Profile areas

A compact route into product identity, peptide link, exposure evidence, context lanes, interpretation boundaries, and reproducible access.

Available

Molecular identity & structure

What is this product, which peptide does it map to, and what is its structure?

ATLPD0000038

Takeda Pharmaceuticals America, Inc. · subcutaneous

Available

Pharmacology

What is the drug used for and how does it act?

Plasma kallikrein inhibitor

Empty

Pharmacokinetics

Are there curated exposure / PK summaries?

0 supporting PK observations

Available

Safety & immunogenicity

What safety, postmarketing, and immune-recognition signals surround the product?

Warning

regulatory warning + context

Available

Clinical & regulatory

What trial and product-label context is attached to this product?

13 trials · 0 labels

Available

Provenance, scope & access

How is the evidence scoped, traced, cited, and reopened?

Record

scope · lineage · access

One. Molecular identity & structure

What the product is: its names and identifiers, the reviewed peptide identity it maps to, and that peptide's chemical / 3D structure.

Identity

Product identity anchor

Ecallantide

ATLPD0000038

This product identity anchors product-level label, trial, postmarketing, and PK context. Route, form, and holder fields are shown when they are normalized from product or label references, not inferred from the product name.

Peptide link

Identity status

1 linked peptide

Product context

13 anchors

0 label · 13 trial

Identity fields

Product name: Ecallantide
ADMETatlas product ID: ATLPD0000038
Aliases / marketed names: Kalbitor
Sponsor / label holder: Takeda Pharmaceuticals America, Inc.
Route: subcutaneous
Dosage form / class: Injection, solution

Identity anchors

These anchors support product-level lookup and context attachment. They are identity evidence, not ADMET endpoint measurements.

Peptide link

Identity status

1 linked peptide

Label references

Product-label context available for this identity.

Trial references

Clinical-trial context attached through product identity.

Name-normalization matches

not available

Review status: —.

Drug classification (ATC)

B06AC03 · ecallantide

ATC classification © WHO Collaborating Centre for Drug Statistics Methodology; used unmodified for non-commercial research.

Linked peptide identity

Link decision

Identity status

Product-level evidence remains attached to this product identity until a reviewed peptide link supports peptide-context interpretation.

Context link

Product-only

context stays product-level

Linked identities

canonical peptide identities

Reference traces

link-supporting references

Reference peptide identity

The public link view emphasizes sequence, identity role, reference support, and interpretation boundary rather than non-public peptide identifiers.

Identity role: Reference identity
Sequence: Open peptide profile for sequence
Residue length: Open peptide profile
Reference support: 1 supporting reference

Open peptide profile

Linked identity set

Multiple linked identities can reflect reviewed source-sequence differences, variant entries, or precursor-like entries. Use the reference identity as the main product-context link.

Reference identity

Canonical sequence

Sequence available in peptide profile

1 supporting reference

Open

Link reference trace1 reference

Linked identity	Reference	Link review
Reference identity	Not linked	Linked peptide identity

Interpretation boundary

The link supports product-context interpretation beside a peptide identity. It is not a measured endpoint, and it does not promote label, safety, or trial context into peptide-level endpoint truth by itself.

2D structure·RDKit.js

rendering molecule…

Canonical SMILES

CC[C@H](C)[C@H]1C(=O)N[C@H](C(=O)NCC(=O)NCC(=O)N[C@H]2CSSC[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N4CCC[C@H]4C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@@H](CSSC[C@@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@@H](CSSC[C@@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)NCC(=O)N5CCC[C@H]5C(=O)N3)CC(=O)O)CC(=O)O)C)CCCCN)CC6=CC=CC=C6)C)NC(=O)[C@H](CC7=CC=CC=C7)NC(=O)[C@H](CO)NC(=O)[C@H](CC8=CN=CN8)NC(=O)[C@H](CCSC)NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)N)C(=O)N[C@@H]([C@H](C)O)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CC(=O)O)C(=O)O)CCSC)CCCCN)CCCCN)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CNC(=O)[C@@H](NC2=O)CCC(=O)O)CC(=O)N)CCC(=O)N)CC(=O)N)CCCNC(=N)N)CC9=CC=CC=C9)CCC(=O)O)CO)CC(C)C)CCC(=O)O)CCC(=O)O)C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N1)CC1=CC=CC=C1)CCC(=O)O)CCC(=O)O)CCC(=O)N)CCCNC(=N)N)[C@H](C)O)CC1=CC=CC=C1)[C@@H](C)CC)CC(=O)N)CC1=CC=CC=C1)CC1=CC=CC=C1)CC1=CNC2=CC=CC=C21)CCCNC(=N)N)CC1=CN=CN1)C)C)CCCNC(=N)N)CC1=CC=C(C=C1)O

Structure shown for the reviewed peptide identity linked to this product (ATLPC0035849). Atom-level 2D depiction rendered from the canonical SMILES.

A 2D graph describes connectivity, not conformation; a 3D reference describes one coordinate model, not the full ensemble.

Open linked peptide · ATLPC0035849

Two. Pharmacology: indication & mechanism

What the drug is used for and how it acts — curated therapeutic indications and mechanism of action for the linked molecule.

Three. Pharmacokinetics & exposure

Curated exposure / PK summaries — absorption, half-life, clearance, volume of distribution — with cited measurements.

Four. Safety & immunogenicity

Regulatory safety warnings, postmarketing and nonclinical safety context, and immune-recognition context. These describe available signals, not incidence rates or causality.

Safety & immunogenicity

Regulatory safety warning

Black Box Warning · immune system toxicity

Postmarketing safety

report entries

Immune recognition

assay entries

Nonclinical safety

context entries

Product context landscape shows 0 of 3 lanes with current signal support for this product.

LaneCountCurrent signalBoundary

Postmarketing safety

No report context attached

report entries

No postmarketing safety report context attached.

Serious: 0 (0%)Reactions: 0Countries: 0

Spontaneous reports are safety-surveillance context only. They do not establish incidence, comparative risk, or causality.External search

Immune recognition

No immune-assay context attached

assay entries

No immune-recognition assay context attached.

Positive: 0Negative: 0MHC classes: 0

Immune-assay entries show epitope or MHC recognition assay context. They are not clinical immunogenicity incidence.Context entries

Nonclinical safety

No nonclinical safety context attached

context entries

No nonclinical safety context attached.

Label refs: 0Reviewed refs: 0Species: 0

Nonclinical safety entries retain animal, toxicology, or label context and are not normalized human safety endpoints.Context entries

The source-level context signal index is deferred from the initial product profile. Use the context-lane links above or the structured product profile below to inspect all 0 retained context signal entries.

Interpretation boundary Product-context signals are retained for interpretation and traceability. They are not incidence rates, causal safety findings, or normalized peptide endpoint measurements.

Five. Clinical & regulatory evidence

Clinical-trial context and structured product-label references attached by product identity.

Clinical & regulatory evidence

Human study context

trial signals

Regulatory label

label contexts

Product context landscape shows 1 of 2 lanes with current signal support for this product.

LaneCountCurrent signalBoundary

Human study context

Study registry context attached

trial signals

NCT01832896: Study to Assess the Tolerability and Safety of Ecallantide in Children and Adolescents With Hereditary Angioedema

Strong NCTs: 13Exact match: 8Has results: 8

Study registry references provide trial context. Phase, status, and posted-results metadata are not endpoint evidence by themselves.Registry search

Regulatory label

Supporting label context

label contexts

No structured label reference attached.

Label refs: 0Reviewed AE: 0Immunogenicity: 0

Product-label entries are regulatory product-label context unless an entry is separately promoted by endpoint-specific policy.Label search

Interpretation boundary Product-context signals are retained for interpretation and traceability. They are not incidence rates, causal safety findings, or normalized peptide endpoint measurements.

Six. Provenance, scope & access

How to read, trace, cite, and reopen this profile: evidence scope, reference lineage, and reproducible data access.

Evidence scope

Profile reading policy

Evidence roles stay separate before interpretation

Endpoint summaries, product-context lanes, identity links, and source references answer different questions. This boundary keeps the page useful without converting context into stronger claims than the current review layer supports.

Endpoint comparison

Held for curated endpoint evidence

Use module 3 when comparing PK summaries or cited measurements.

Product-context reading

Context lane ready for reviewed signals

Use module 4 for label, trial, safety, immune, and nonclinical context.

Context propagation

Held until link review

Identity status

Interpretation matrix

SurfaceEvidence roleSupportsDoes not supportDrilldown

Curated endpoint evidence

Evidence role

Comparable measurement layer

Supports

Endpoint-level interpretation when context fields match.

Does not support

Pooled product parameters across mismatched species, units, route, dose, matrix, population, or source context.

Module 3

Product-context signals

Evidence role

Clinical, label, safety, immune, and nonclinical context

Supports

Reading the product's evidence surroundings and source-backed context lanes.

Does not support

Incidence rates, causality claims, product safety ranking, or normalized ADMET endpoint values.

Module 4

Peptide link and identity map

Evidence role

Product-to-peptide interpretation gate

Supports

Whether product context can be read beside a reviewed peptide identity.

Does not support

Automatic transfer of every product-level signal to peptide-level endpoint evidence.

Module 2

Reference lineage

Evidence role

Reproducibility and source trace

Supports

Checking where labels, trials, safety reports, identity links, and curated measurements came from.

Does not support

A substitute for normalized evidence, context grouping, or endpoint review.

Module 6

External source references

Evidence role

Original-source reading path

Supports

Reading the source reference in its native regulatory, registry, literature, or source context.

Does not support

Bypassing ADMETatlas curation status, interpretation boundaries, or endpoint-promotion policy.

Sources

Review gates

Endpoint promotion

Endpoint-specific review

Context propagation

Product-level reading

Causality and incidence

Not claimed from context counts

Reference lineage

Reference role map

Source families are separated by scientific role

Label, trial, safety, immune, identity-link, and PK evidence enter the product profile through different review paths. This module keeps their roles visible so users can trace evidence without over-reading context counts.

Source material

active reference families

Identity review

link reference traces

Evidence lanes

PK plus context entries

Release view

public

current product profile

Reference role matrix

Source familyEvidence roleSupportsBoundaryDrilldown

Label material

0 label · 0 sections

Evidence role

Regulatory product-label context

Supports

Label sections, label-derived PK statements, safety wording, route, formulation, and immunogenicity context when extracted.

Boundary

Label material supports product context. It becomes endpoint evidence only through the reviewed PK or endpoint extraction path.

Module 4

Trial registry context

13 references

Evidence role

Human study-registration context

Supports

Trial identity, phase/status, intervention matching, and availability of results context around the product.

Boundary

Trial registry entries are study context unless endpoint-compatible results are extracted and reviewed separately.

Module 4

Postmarketing reports

0 AE context entries

Evidence role

Safety surveillance context

Supports

Signal-aware reading of reported adverse-event context around marketed products.

Boundary

Report counts do not establish causality, incidence, or comparative product safety.

Module 4

Immune and nonclinical context

0 entries

Evidence role

Assay and nonclinical support context

Supports

Immune-recognition assays, nonclinical safety context, and neighboring signals that help interpret the product profile.

Boundary

These entries are not clinical incidence or endpoint truth unless a review policy promotes a specific endpoint.

Module 4

Link references

1 traces

Evidence role

Product-peptide identity support

Supports

Reviewed product-to-peptide linkage and context propagation decisions.

Boundary

Link references support identity interpretation, not measured ADMET endpoint values.

Module 2

Cited PK evidence

0 entries

Evidence role

Endpoint measurement trace

Supports

Rechecking source values, units, route, dose, matrix, population, and source context for PK summaries.

Boundary

PK entries remain context-bound measurements and should not be pooled across incompatible contexts.

Module 3

Traceability note

Link references and selected label entries carry direct source links. Product-context entries may instead carry source labels and curated summaries in the structured profile. Both are provenance, but only direct reference fields should be displayed as citation links.

Data access & citation

Reproducible product view

The structured profile access reopens the same product view used by this page, including identity, peptide link, PK evidence trace, context lanes, and reference lineage for the current public release.

Current public release

ATL product ID

ATLPD0000038

public product profile

Linked peptides

identity link scope

PK evidence

cited measurement trace

Context signals

product-context entries

References

label plus link traces

Analysis-ready access

Use the product profile access for product-specific reproducibility. Use full-release downloads for catalog-scale analysis, with the current source policy and data dictionary.

Structured product profile

Scope

Current product

Contents

Machine-readable profile for identity, peptide link, PK evidence summaries, context signals, and reference lineage.

Boundary

Uses the public ATL product ID in the URL. Non-public product identifiers remain outside the navigation label.

Open profile data

Programmatic access

The request returns the structured product profile used by this page. It is the current product-specific reproducibility path while product-only tabular exports remain a release follow-up.

GET /products/ATLPD0000038

open

curl -sS 'https://admetatlas.scbdd.com/products/ATLPD0000038' \
  -H 'accept: application/json' \
  -H 'X-Visibility: public_release'

Use boundary

Use this module to reproduce the current product profile and locate full-release exports. Cross-product comparison still depends on compatible endpoint, species, route, dose, matrix, population, source, identity-link, and review context.