Peptide·plain sequence-like

Vosoritide

ATLPC0004440

PGQEHPNARKYKGANKKGLSKGCFGLKLDRIGSMSGLGC

Routes

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Length
39 aa
Monoisotopic mass
4102.1 Da
Net charge @ pH 7.4
6.10
Isoelectric point
10.58
GRAVY
-0.774

Coveragecounts only · not riskATLPC0004440

Measurements
16
Endpoints
8
Domains
3/5
Products
1

No matrix stability evidence
7 clearance measurements
Product-level review pending
3 liability motifs

Jump to domain

Open the matching evidence section below

All evidence index · 16

Exposure / Absorption

7 measurements

Distribution / Barrier

2 measurements

Metabolic & Proteolytic Stability

No evidence

Excretion / Persistence

7 measurements

Toxicity / Safety

No evidence

Sequence & molecular identity

1 forms

Reviewed sequence, peptidoform forms, chemical representation, 3D references, and covalent topology used to interpret this peptide identity.

Sequence & peptidoform

Identity summaryCanonical sequence only

Identity status: Canonical sequence only
Residues: 39
Peptidoform features: 0
Documented molecular forms: 1
Representations: 2

Documented molecular forms1 form linked to this peptide identity

Form	Topology	Modifications	Connections	Representations	Measurements
ATLPF0004840	—	—	—	Notation only	1

Residue view

Residue display

39 residues

P1G2Q3E4H5P6N7A8R9K10Y11K12G13A14N15K16K17G18L19S20K21G22C23F24G25L26K27L28D29R30I31G32S33M34S35G36L37G38C39

Side-chain classNonpolarPolarBasic (+)Acidic (−)Modified

Soft tints mark standard side-chain classes for scanning. Primary emphasis is reserved for reported modifications, termini, secondary-structure tracks, and topology links.

Peptidoform features

Features are shown only when a reported notation or topology record supports them.

No terminal modification, residue-level marker, disulfide, staple, coordination, or other topology signal is currently available.

Structure & chemistry

Chemical representationsequence / HELM only

Representation class

How the current release can interpret this identity chemically.

plain sequence-like

Parent-residue sequence

Residue string used for positional interpretation when available.

PGQEHPNARKYKGANKKGLSKGCFGLKLDRIGSMSGLGC

HELM

Polymer notation for modified peptide representation when available.

Not available

SMILES

Chemical graph string used for atom-level 2D depiction when available.

Not available

No atom-level graph

A reviewed SMILES is required before a 2D molecular depiction can be shown. Sequence and HELM remain useful for identity interpretation, but they do not replace a chemical graph.

3D structure references1 reference

3D coordinates·Sequence matchexperimental

Sequence match·reference selected·identity 100.0%·confidence experimental

Link	Method	Confidence	Match
Open	Sequence match	experimental	100.0% identity

Covalent topology & modificationsnone

Exact topology not established

No reviewed form-level topology or residue-level connection annotation is attached to this peptide in the current release. This is not evidence that every molecular form is linear or unmodified.

Physicochemical profile

4 descriptors

Computed sequence-derived descriptors and any measured physicochemical evidence such as lipophilicity. Computed values are interpretation aids, not experimental ADMET measurements.

Core descriptors39 aa · pI 10.6 · GRAVY -0.77

Length: 39 aa
Monoisotopic mass: 4102.11 Da
Average mass: 4104.78 Da
Net charge at pH 7.4: 6.10
Estimated pI: 10.58
GRAVY: -0.774
KD-positive residues: 28.2%
Aromatic residues: 5.1%

Developability interpretation

Ionization context: pH 7.4 separated from pI
Hydrophobicity balance: Leans hydrophilic
Amphipathic moment (μH): 0.06
Computation boundary: Standard-sequence only

Charge & residue composition

pH charge context

Modeled net charge across common formulation and assay pH checkpoints.

pH 2

9.96

pH 5

7.19

pH 6

6.78

pH 7.4

5.90

pH 9

3.60

pH 12

-4.11

Residue-class composition

Grouped composition is often more interpretable than a long amino-acid list.

Acidic (D,E)

2 · 5.1%

Basic (K,R,H)

9 · 23.1%

Polar uncharged (N,Q,S,T)

6 · 15.4%

Hydrophobic aliphatic (A,V,I,L,M)

8 · 20.5%

Aromatic (F,W,Y)

2 · 5.1%

Conformational / sulfur (G,P,C)

12 · 30.8%

Top residues

G820.5%K615.4%L410.3%S37.7%A25.1%R25.1%N25.1%C25.1%

Hydropathy & amphipathic windows

Hydropathy windows

Seven-residue sliding windows expose local patches hidden by whole-sequence GRAVY.

Most hydrophobic window

22-28

GCFGLKL

GRAVY 1.171

Most hydrophilic window

4-10

EHPNARK

GRAVY -2.629

33 local hydropathy windows scanned. A local patch is context for solubility, adsorption, and membrane interaction review, not a standalone endpoint.

Amphipathic-window scan

Top alpha-helix hydrophobic-moment windows across 12, 15, 18, and 21 residues.

12 aa window

16-27

KKGLSKGCFGLK

μH 1.08 · charge 4.0

12 aa window

28-39

LDRIGSMSGLGC

μH 0.89 · charge 0.0

12 aa window

17-28

KGLSKGCFGLKL

μH 0.86 · charge 3.0

12 aa window

22-33

GCFGLKLDRIGS

μH 0.85 · charge 1.0

12 aa window

15-26

NKKGLSKGCFGL

μH 0.84 · charge 3.0

Sequence-liability cues

Sequence-liability notes

Motifs are review prompts for formulation or CMC interpretation; they are not degradation predictions.

Oxidation-sensitive residues

M, C · pos 23, 34, 39

Met, Trp, and Cys residues can merit formulation review for oxidation or covalent-state sensitivity.

Cys covalent complexity

C · pos 23, 39

Multiple cysteines can indicate disulfide or free-thiol interpretation requirements.

Pro/Gly-rich sequence

P/G · pos 1, 2, 6, 13, 18, 22 +4

High Pro/Gly content can affect local flexibility and secondary-structure propensity.

Alpha-helix amphipathic projection

Helical wheel · Edmundson projection

μ_H = 0.06100°/residue · 39 aa

Hydrophobic moment0.06

Mean K-D hydropathy-0.77

Approx. net charge+6

Projection angle100° / residue

The pale sector marks the direction of the hydrophobic face inferred from μ_H. This is a projection assumption, not a measured fold.

HydrophobicAromaticPolarBasic +Acidic −Specialhydrophobic faceμ_H arrow → hydrophobic face

The projection assumes an α-helix conformation; a long μ_H arrow indicates an amphipathic helix, common in antimicrobial peptides.Sequence > 30 aa — only termini and every fifth position are numbered because later turns share earlier wheel angles.

Method notes

Charge model: side-chain pKa D 3.9, E 4.1, C 8.5, Y 10.1, H 6.5, K 10.8, R 12.5 with EMBOSS termini. pI is estimated by binary search on modeled net charge. Hydropathy uses Kyte-Doolittle values; hydrophobic moment follows the Eisenberg alpha-helix vector-sum convention. When the basis is a parent-residue sequence, modified chemistry is intentionally not inferred.

Computed developability descriptors

Deterministic descriptors computed from the reviewed sequence or chemical structure (RDKit), each anchored to a literature method. These are computed estimates for developability interpretation — not experimental measurements — and are validated against independent reference implementations.

Sequence-derived

Computed from the standard parent-residue sequence; protein-origin metrics defined at any length.

Aliphatic index

55.13

Instability index

14.3

At or below 40 — predicted stable in vitro.

Boman index

1.77 kcal/mol

Molar extinction coefficient (280 nm)

1,490 M⁻¹·cm⁻¹

A280 (1 g/L) ≈ 0.36 · 1,615 M⁻¹·cm⁻¹ with 1 disulfide

Structure-derived descriptors are not shown because this identity has no resolved chemical structure (SMILES). This is a known coverage gap for disulfide-rich and unresolved peptidoforms, not a computation error.

Exposure / Absorption

7 records

What evidence describes systemic exposure or absorption?

Evidence records

Complete canonical measurements and observations attached to this domain.

Endpoint scope

Formal ADMET endpoints represented for this peptide.

Matched-context analysis

Quantitative results that may be analysed only with scientifically compatible records.

Reported-result review

Qualitative, narrative, or review-first results interpreted in their source context.

Endpoints in scopeTmax Cmax AUC Bioavailability

Evidence interpretation

Result type, analysis use, and source-check status are kept separate so a numerical value is not mistaken for a universally comparable result.

Eligible for matched-context analysis

Quantitative results whose endpoint and context must still be matched before analysis.

Interpret as reported

Qualitative, narrative, or review-first findings preserved in source context.

Supporting context only

Reference, label, clinical, or supporting context for interpretation.

Review before analysis

Records whose present structure does not establish a safe analysis role.

Evidence by endpoint

Rows are grouped by endpoint so value, assay context, interpretation layer, and reference can be checked in place.

Bioavailability1 record · 0 matched-context · 1 as reported · 0 context only · 0 review required

#	Value	Analysis use	Assay / model	Result context	Reference
1	Observation Absolute bioavailability for vosoritide following subcutaneous injection was not determined.	Interpret as reported	human	Result: Qualitative or narrative result · Molecular form: not reported · Route: subcutaneous · Vosoritide· 12.3 Pharmacokinetics · bioavailability not determined text · Absolute bioava... · Source: Primary reference linked	Reference

AUC3 records · 0 matched-context · 3 as reported · 0 context only · 0 review required

#	Value	Analysis use	Assay / model	Result context	Reference
1	Observation The area under the concentration-time curve (AUC) and peak concentration (C max ) of vosoritide increased greater than proportionally following subcutaneous administration to pediatric subjects with achondroplasia in the dose range of 7.5 to 30.0 mcg/kg.	Interpret as reported	human	Result: Qualitative or narrative result · Molecular form: not reported · Route: subcutaneous · Vosoritide· 12.3 Pharmacokinetics · cmax auc greater than dose proportionality text · The... · Source: Primary reference linked	Reference
2	Observation The mean AUC 0-t at week 52 increased approximately 20% compared to that at day 1.	Interpret as reported	human	Result: Qualitative or narrative result · Molecular form: not reported · Vosoritide· 12.3 Pharmacokinetics · auc longitudinal increase text · The mean AUC 0-t at... · Source: Primary reference linked	Reference
3	161-290 ng*min/mL	Use only explicitly reported fields	human	Result: Interval measurement · Molecular form: not reported · Vosoritide· 12.3 Pharmacokinetics · auc mean sd range respectively · The mean (± SD) C ma... · Source: Primary reference linked	Reference

Cmax2 records · 0 matched-context · 2 as reported · 0 context only · 0 review required

#	Value	Analysis use	Assay / model	Result context	Reference
1	Observation The area under the concentration-time curve (AUC) and peak concentration (C max ) of vosoritide increased greater than proportionally following subcutaneous administration to pediatric subjects with achondroplasia in the dose range of 7.5 to 30.0 mcg/kg.	Interpret as reported	human	Result: Qualitative or narrative result · Molecular form: not reported · Route: subcutaneous · Vosoritide· 12.3 Pharmacokinetics · cmax auc greater than dose proportionality text · The... · Source: Primary reference linked	Reference
2	4.71-7.18 ng/mL	Use only explicitly reported fields	human	Result: Interval measurement · Molecular form: not reported · Vosoritide· 12.3 Pharmacokinetics · cmax mean sd range respectively · The mean (± SD) C m... · Source: Primary reference linked	Reference

Tmax1 record · 0 matched-context · 1 as reported · 0 context only · 0 review required

#	Value	Analysis use	Assay / model	Result context	Reference
1	15 minutes 900 seconds	Use only explicitly reported fields	human	Result: Reported point value · Molecular form: not reported · Vosoritide· 12.3 Pharmacokinetics · tmax of value · Vosoritide was absorbed with a median... · Source: Primary reference linked	Reference

Distribution / Barrier

2 records

What is known about distribution, binding, permeability, or barrier crossing?

Evidence records

Complete canonical measurements and observations attached to this domain.

Endpoint scope

Formal ADMET endpoints represented for this peptide.

Matched-context analysis

Quantitative results that may be analysed only with scientifically compatible records.

Reported-result review

Qualitative, narrative, or review-first results interpreted in their source context.

Endpoints in scopePlasma protein binding Vd

Evidence interpretation

Result type, analysis use, and source-check status are kept separate so a numerical value is not mistaken for a universally comparable result.

Eligible for matched-context analysis

Quantitative results whose endpoint and context must still be matched before analysis.

Interpret as reported

Qualitative, narrative, or review-first findings preserved in source context.

Supporting context only

Reference, label, clinical, or supporting context for interpretation.

Review before analysis

Records whose present structure does not establish a safe analysis role.

Evidence by endpoint

Rows are grouped by endpoint so value, assay context, interpretation layer, and reference can be checked in place.

Vd1 record · 0 matched-context · 1 as reported · 0 context only · 0 review required

#	Value	Analysis use	Assay / model	Result context	Reference
1	2880-3020 mL/kg	Use only explicitly reported fields	human	Result: Interval measurement · Molecular form: not reported · Route: subcutaneous · Vosoritide· 12.3 Pharmacokinetics · volume of distribution mean sd range · Distribution T... · Source: Primary reference linked	Reference

Plasma protein binding1 record · 0 matched-context · 1 as reported · 0 context only · 0 review required

#	Value	Analysis use	Assay / model	Result context	Reference
1	Observation plasma protein binding not determined due to hydrolysis of vosoritide in human plasma	Interpret as reported	FDA Integrated Review Table 5 manual extraction · human · plasma	Result: Qualitative or narrative result · Molecular form: not reported · Source: Primary reference linked	Reference

Barrier and permeability assay context

PAMPA, Caco-2, MDCK/RRCK, and BBB findings are assay/model contexts under Distribution / Barrier. They should not be read as interchangeable measurements.

PAMPA

artificial membrane

Caco-2

cell monolayer

MDCK

cell monolayer

RRCK

cell monolayer

BBB

barrier evidence

Excretion / Persistence

7 records

What evidence describes clearance or persistence?

Evidence records

Complete canonical measurements and observations attached to this domain.

Endpoint scope

Formal ADMET endpoints represented for this peptide.

Matched-context analysis

Quantitative results that may be analysed only with scientifically compatible records.

Reported-result review

Qualitative, narrative, or review-first results interpreted in their source context.

Endpoints in scopeHalf Life Clearance

Evidence interpretation

Result type, analysis use, and source-check status are kept separate so a numerical value is not mistaken for a universally comparable result.

Eligible for matched-context analysis

Quantitative results whose endpoint and context must still be matched before analysis.

Interpret as reported

Qualitative, narrative, or review-first findings preserved in source context.

Supporting context only

Reference, label, clinical, or supporting context for interpretation.

Review before analysis

Records whose present structure does not establish a safe analysis role.

Evidence by endpoint

Rows are grouped by endpoint so value, assay context, interpretation layer, and reference can be checked in place.

Clearance1 record · 0 matched-context · 1 as reported · 0 context only · 0 review required

#	Value	Analysis use	Assay / model	Result context	Reference
1	79.4-104 mL/min/kg	Use only explicitly reported fields	human	Result: Interval measurement · Molecular form: not reported · Route: subcutaneous · Vosoritide· 12.3 Pharmacokinetics · clearance mean sd range · Elimination The mean (± SD)... · Source: Primary reference linked	Reference

Half Life6 records · 0 matched-context · 6 as reported · 0 context only · 0 review required

#	Value	Analysis use	Assay / model	Result context	Reference
1	systemic pk half life unspecified phase: 0.35 Hours 1260 seconds	Use only explicitly reported fields	competitive radioimmunoassay · monkey · Cynomolgus monkeys plasma	Result: Reported point value · Molecular form: ATLPF0004840 · Route: SC · Cynomolgus monkeys plasma protease · In Vivo · Source: Primary reference linked	Reference
2	systemic pk half life unspecified phase: 21 Minutes 1260 seconds	Use only explicitly reported fields	ELISA · human · Human plasma	Result: Reported point value · Molecular form: ATLPF0040998 · Route: SC · Human plasma protease · In Vivo · Source: Primary reference linked	Reference
3	systemic pk half life unspecified phase: 27.9 Minutes 1674 seconds	Use only explicitly reported fields	ELISA · human · Human plasma	Result: Reported point value · Molecular form: ATLPF0040998 · Route: SC · Human plasma protease · In Vivo · Source: Primary reference linked	Reference
4	systemic pk half life unspecified phase: 24.4 Minutes 1464 seconds	Use only explicitly reported fields	ELISA · human · Human plasma	Result: Reported point value · Molecular form: ATLPF0040998 · Route: SC · Human plasma protease · In Vivo · Source: Primary reference linked	Reference
5	systemic pk half life unspecified phase: 26.6 Minutes 1596 seconds	Use only explicitly reported fields	ELISA · human · Human plasma	Result: Reported point value · Molecular form: ATLPF0040998 · Route: SC · Human plasma protease · In Vivo · Source: Primary reference linked	Reference
6	systemic pk half life unspecified phase: 27 Minutes 1620 seconds	Use only explicitly reported fields	ELISA · human · Human plasma	Result: Reported point value · Molecular form: ATLPF0040998 · Route: SC · Human plasma protease · In Vivo · Source: Primary reference linked	Reference

Evidence landscape

16 records

Cross-domain evidence distribution and measurement-level detail; the domain modules above show evidence in context, and every row remains available for audit here.

Evidence landscape

A cross-domain view of evidence volume, scientifically permitted analysis use, and source traceability.

ADMET domain

Eligible when context matches

Interpret as reported

Supporting context only

Review before analysis

Exposure / Absorption

7 evidence records

Distribution / Barrier

2 evidence records

Metabolic & Proteolytic Stability

0 evidence records

Excretion / Persistence

7 evidence records

Toxicity / Safety

0 evidence records

Endpoint distribution

Top evidence-bearing endpoint questions.

Half Life

Area Under Curve

Max Concentration

Bioavailability

Clearance

Plasma Protein Binding

Time To Max Concentration

Volume Of Distribution

Assay context

Broad context buckets, useful before comparing values.

In vivo / route

Traceability

Reference-link availability for measurement-level audit.

Linked reference

Not linked

All evidence index

Every evidence record remains available for audit and drilldown. Counts describe evidence volume, not confidence.

DomainAnalysis useReferenceSpecies

#	ADMET domain	Endpoint	Reported value	Result type	Analysis use	Assay / model	Condition	Reference
1	Excretion / Persistence Persistence	Half Life	21 Minutes 1,260 seconds Result metric: SYSTEMIC_PK_HALF_LIFE_UNSPECIFIED_PHASE	Reported point value	Use only explicitly reported fields	ELISA · human · Human plasma	Route: SC · Protease: Human plasma protease · In Vivo	Reference Primary reference linked
2	Excretion / Persistence Persistence	Half Life	0.35 Hours 1,260 seconds Result metric: SYSTEMIC_PK_HALF_LIFE_UNSPECIFIED_PHASE	Reported point value	Use only explicitly reported fields	competitive radioimmunoassay · monkey · Cynomolgus monkeys plasma	Route: SC · Protease: Cynomolgus monkeys plasma protease · In Vivo	Reference Primary reference linked
3	Excretion / Persistence Persistence	Half Life	27.9 Minutes 1,674 seconds Result metric: SYSTEMIC_PK_HALF_LIFE_UNSPECIFIED_PHASE	Reported point value	Use only explicitly reported fields	ELISA · human · Human plasma	Route: SC · Protease: Human plasma protease · In Vivo	Reference Primary reference linked
4	Excretion / Persistence Persistence	Half Life	24.4 Minutes 1,464 seconds Result metric: SYSTEMIC_PK_HALF_LIFE_UNSPECIFIED_PHASE	Reported point value	Use only explicitly reported fields	ELISA · human · Human plasma	Route: SC · Protease: Human plasma protease · In Vivo	Reference Primary reference linked
5	Excretion / Persistence Persistence	Half Life	26.6 Minutes 1,596 seconds Result metric: SYSTEMIC_PK_HALF_LIFE_UNSPECIFIED_PHASE	Reported point value	Use only explicitly reported fields	ELISA · human · Human plasma	Route: SC · Protease: Human plasma protease · In Vivo	Reference Primary reference linked
6	Excretion / Persistence Persistence	Half Life	27 Minutes 1,620 seconds Result metric: SYSTEMIC_PK_HALF_LIFE_UNSPECIFIED_PHASE	Reported point value	Use only explicitly reported fields	ELISA · human · Human plasma	Route: SC · Protease: Human plasma protease · In Vivo	Reference Primary reference linked
7	Distribution / Barrier Distribution	Plasma Protein Binding	Observation plasma protein binding not determined due to hydrolysis of vosoritide in human plasma	Qualitative or narrative result	Interpret as reported	FDA Integrated Review Table 5 manual extraction · human · plasma	Table 5 reports the endpoint as not determined rather than a numeric binding value · retain as text evidence to explain the missing PPB value.	Reference Primary reference linked
8	Exposure / Absorption Exposure	Time To Max Concentration	15 minutes 900 seconds	Reported point value	Use only explicitly reported fields	human	Not specified	Reference Primary reference linked
9	Exposure / Absorption Exposure	Max Concentration	4.71-7.18 ng/mL	Interval measurement	Use only explicitly reported fields	human	Not specified	Reference Primary reference linked
10	Exposure / Absorption Exposure	Area Under Curve	161-290 ng*min/mL	Interval measurement	Use only explicitly reported fields	human	Not specified	Reference Primary reference linked

1–10 / 16

Product context

1 products

Product-level route, label, and clinical context that frames peptide-level evidence. A peptide-level summary only; product pages keep the full drilldown.

Summary1 linked product

Linked products: 1
Label context: None
Clinical trials: 17
Safety label cues: None

Linked products1 shown

Vosoritide

Peptide-product match

Unique peptide match

Route / product class

subcutaneous · Kit

Clinical context

17 trial records · 13 exact intervention matches · 3 with results · latest 2026-04-22

Label safety context

No label safety cue linked

View product

Identity & reference map

16 sources

Reference-level support for checking reported names, sequence notation, and peptide identity agreement.

Summary4 reference groups

Identity type: canonical sequence
Reported notation: 0
Reference groups: 4
Measurements: 16
ATL peptide ID: ATLPC0004440

Identity concordance

Exact reported notation

Reported sequence string matches the current peptide notation.

0 / 16

Parent-residue compatible

Reported notation differs, but resolves to the same parent-residue display.

0 / 16

Different notation

Reported notation does not resolve to the current display sequence.

0 / 16

Source sequence not captured

No source-specific sequence was captured for comparison; this is not interpreted as agreement or disagreement.

16 / 16

Reported sequence notation

No source-specific sequence notation has been captured in the current identity references.

Current identity

PGQEHPNARKYKGANKKGLSKGCFGLKLDRIGSMSGLGC

Reported names

No distinct human-readable aliases are exposed.

Reference map4 reference groups

Reference map

Grouped by reference link, with endpoint scope and reported identity kept visible.

Reference	Supports	Reported identity	Records
Reference Open	DistributionExposurePersistence Area Under Curve, Bioavailability, Clearance, Max Concentration +2 more	No reported alias	9 identity 9 evidence
Reference Open	Persistence Half Life	No reported alias	5 identity 5 evidence
Reference Open	Persistence Half Life	No reported alias	1 identity 1 evidence
Reference Open	Distribution Plasma Protein Binding	No reported alias	1 identity 1 evidence

Data access & reproducibility

Stable record access, analysis-ready files, and scripted retrieval for reproducing this profile view.

Record scopePublic release

ATL peptide ID: ATLPC0004440
Identity type: canonical sequence
ADMET endpoints: 8
Evidence records: 16
Reference groups: 4
Release view: Public release

Data access

Structured peptide profile

JSON

Peptide-specific profile used by this page, including identity and evidence context.

Open JSON

Peptide catalogue

TSV

Complete frozen peptide table. Filter the ATL peptide ID column locally to isolate this record.

Download catalogue

Measurement catalogue

TSV

Complete frozen measurement table. Join or filter by ATL peptide ID for peptide-level analysis.

Download measurements

Programmatic access

The request returns the same structured peptide record used by this profile. The tabular downloads are complete frozen release tables and should be filtered locally by ATL peptide ID.

Open endpoint

GET /api/v1/peptides/ATLPC0004440

open

curl -sS 'https://admetatlas.scbdd.com/api/v1/peptides/ATLPC0004440' \
  -H 'accept: application/json' \
  -H 'X-Visibility: public_release'

Form

Topology

Modifications

Connections

Representations

Measurements

ATLPF0004840

—

Notation only

Link

Method

Confidence

Match

Open

Sequence match

experimental

100.0% identity

Value

Analysis use

Assay / model

Result context

Reference

Observation

Absolute bioavailability for vosoritide following subcutaneous injection was not determined.

Interpret as reported

human

Result: Qualitative or narrative result · Molecular form: not reported · Route: subcutaneous · Vosoritide· 12.3 Pharmacokinetics · bioavailability not determined text · Absolute bioava... · Source: Primary reference linked

Reference

Value

Analysis use

Assay / model

Result context

Reference

Observation

The area under the concentration-time curve (AUC) and peak concentration (C max ) of vosoritide increased greater than proportionally following subcutaneous administration to pediatric subjects with achondroplasia in the dose range of 7.5 to 30.0 mcg/kg.

Interpret as reported

human

Result: Qualitative or narrative result · Molecular form: not reported · Route: subcutaneous · Vosoritide· 12.3 Pharmacokinetics · cmax auc greater than dose proportionality text · The... · Source: Primary reference linked

Reference

Observation

The mean AUC 0-t at week 52 increased approximately 20% compared to that at day 1.

Interpret as reported

human

Result: Qualitative or narrative result · Molecular form: not reported · Vosoritide· 12.3 Pharmacokinetics · auc longitudinal increase text · The mean AUC 0-t at... · Source: Primary reference linked

Reference

161-290 ng*min/mL

Use only explicitly reported fields

human

Result: Interval measurement · Molecular form: not reported · Vosoritide· 12.3 Pharmacokinetics · auc mean sd range respectively · The mean (± SD) C ma... · Source: Primary reference linked

Reference

Value

Analysis use

Assay / model

Result context

Reference

Observation

Interpret as reported

human

Reference

4.71-7.18 ng/mL

Use only explicitly reported fields

human

Result: Interval measurement · Molecular form: not reported · Vosoritide· 12.3 Pharmacokinetics · cmax mean sd range respectively · The mean (± SD) C m... · Source: Primary reference linked

Reference

Value

Analysis use

Assay / model

Result context

Reference

15 minutes

900 seconds

Use only explicitly reported fields

human

Result: Reported point value · Molecular form: not reported · Vosoritide· 12.3 Pharmacokinetics · tmax of value · Vosoritide was absorbed with a median... · Source: Primary reference linked

Reference

Value

Analysis use

Assay / model

Result context

Reference

2880-3020 mL/kg

Use only explicitly reported fields

human

Result: Interval measurement · Molecular form: not reported · Route: subcutaneous · Vosoritide· 12.3 Pharmacokinetics · volume of distribution mean sd range · Distribution T... · Source: Primary reference linked

Reference

Value

Analysis use

Assay / model

Result context

Reference

Observation

plasma protein binding not determined due to hydrolysis of vosoritide in human plasma

Interpret as reported

FDA Integrated Review Table 5 manual extraction · human · plasma

Result: Qualitative or narrative result · Molecular form: not reported · Source: Primary reference linked

Reference

Value

Analysis use

Assay / model

Result context

Reference

79.4-104 mL/min/kg

Use only explicitly reported fields

human

Result: Interval measurement · Molecular form: not reported · Route: subcutaneous · Vosoritide· 12.3 Pharmacokinetics · clearance mean sd range · Elimination The mean (± SD)... · Source: Primary reference linked

Reference

Value

Analysis use

Assay / model

Result context

Reference

systemic pk half life unspecified phase: 0.35 Hours

1260 seconds

Use only explicitly reported fields

competitive radioimmunoassay · monkey · Cynomolgus monkeys plasma

Result: Reported point value · Molecular form: ATLPF0004840 · Route: SC · Cynomolgus monkeys plasma protease · In Vivo · Source: Primary reference linked

Reference

systemic pk half life unspecified phase: 21 Minutes

1260 seconds

Use only explicitly reported fields

ELISA · human · Human plasma

Result: Reported point value · Molecular form: ATLPF0040998 · Route: SC · Human plasma protease · In Vivo · Source: Primary reference linked

Reference

systemic pk half life unspecified phase: 27.9 Minutes

1674 seconds

Use only explicitly reported fields

ELISA · human · Human plasma

Result: Reported point value · Molecular form: ATLPF0040998 · Route: SC · Human plasma protease · In Vivo · Source: Primary reference linked

Reference

systemic pk half life unspecified phase: 24.4 Minutes

1464 seconds

Use only explicitly reported fields

ELISA · human · Human plasma

Result: Reported point value · Molecular form: ATLPF0040998 · Route: SC · Human plasma protease · In Vivo · Source: Primary reference linked

Reference

systemic pk half life unspecified phase: 26.6 Minutes

1596 seconds

Use only explicitly reported fields

ELISA · human · Human plasma

Result: Reported point value · Molecular form: ATLPF0040998 · Route: SC · Human plasma protease · In Vivo · Source: Primary reference linked

Reference

systemic pk half life unspecified phase: 27 Minutes

1620 seconds

Use only explicitly reported fields

ELISA · human · Human plasma

Result: Reported point value · Molecular form: ATLPF0040998 · Route: SC · Human plasma protease · In Vivo · Source: Primary reference linked

Reference

ADMET domain

Endpoint

Reported value

Result type

Analysis use

Assay / model

Condition

Reference

Excretion / Persistence

Persistence

Half Life

21 Minutes

1,260 seconds

Result metric: SYSTEMIC_PK_HALF_LIFE_UNSPECIFIED_PHASE

Reported point value

Use only explicitly reported fields

ELISA · human · Human plasma

Route: SC · Protease: Human plasma protease · In Vivo

Reference

Primary reference linked

Excretion / Persistence

Persistence

Half Life

0.35 Hours

1,260 seconds

Result metric: SYSTEMIC_PK_HALF_LIFE_UNSPECIFIED_PHASE

Reported point value

Use only explicitly reported fields

competitive radioimmunoassay · monkey · Cynomolgus monkeys plasma

Route: SC · Protease: Cynomolgus monkeys plasma protease · In Vivo

Reference

Primary reference linked

Excretion / Persistence

Persistence

Half Life

27.9 Minutes

1,674 seconds

Result metric: SYSTEMIC_PK_HALF_LIFE_UNSPECIFIED_PHASE

Reported point value

Use only explicitly reported fields

ELISA · human · Human plasma

Route: SC · Protease: Human plasma protease · In Vivo

Reference

Primary reference linked

Excretion / Persistence

Persistence

Half Life

24.4 Minutes

1,464 seconds

Result metric: SYSTEMIC_PK_HALF_LIFE_UNSPECIFIED_PHASE

Reported point value

Use only explicitly reported fields

ELISA · human · Human plasma

Route: SC · Protease: Human plasma protease · In Vivo

Reference

Primary reference linked

Excretion / Persistence

Persistence

Half Life

26.6 Minutes

1,596 seconds

Result metric: SYSTEMIC_PK_HALF_LIFE_UNSPECIFIED_PHASE

Reported point value

Use only explicitly reported fields

ELISA · human · Human plasma

Route: SC · Protease: Human plasma protease · In Vivo

Reference

Primary reference linked

Excretion / Persistence

Persistence

Half Life

27 Minutes

1,620 seconds

Result metric: SYSTEMIC_PK_HALF_LIFE_UNSPECIFIED_PHASE

Reported point value

Use only explicitly reported fields

ELISA · human · Human plasma

Route: SC · Protease: Human plasma protease · In Vivo

Reference

Primary reference linked

Distribution / Barrier

Distribution

Plasma Protein Binding

Observation

plasma protein binding not determined due to hydrolysis of vosoritide in human plasma

Qualitative or narrative result

Interpret as reported

FDA Integrated Review Table 5 manual extraction · human · plasma

Table 5 reports the endpoint as not determined rather than a numeric binding value · retain as text evidence to explain the missing PPB value.

Reference

Primary reference linked

Exposure / Absorption

Exposure

Time To Max Concentration

15 minutes

900 seconds

Reported point value

Use only explicitly reported fields

human

Not specified

Reference

Primary reference linked

Exposure / Absorption

Exposure

Max Concentration

4.71-7.18 ng/mL

Interval measurement

Use only explicitly reported fields

human

Not specified

Reference

Primary reference linked

Exposure / Absorption

Exposure

Area Under Curve

161-290 ng*min/mL

Interval measurement

Use only explicitly reported fields

human

Not specified

Reference

Primary reference linked

Reference

Supports

Reported identity

Records

Reference

Open

DistributionExposurePersistence

Area Under Curve, Bioavailability, Clearance, Max Concentration +2 more

No reported alias

9 identity

9 evidence

Reference

Open

Persistence

Half Life

No reported alias

5 identity

5 evidence

Reference

Open

Persistence

Half Life

No reported alias

1 identity

1 evidence

Reference

Open

Distribution

Plasma Protein Binding

No reported alias

1 identity

1 evidence