证据内容以英文维护。

Carperitide 的理想化结构描述

由序列构建的理想化构象;并非实验结构或预测结构。

速览

ENTRY TYPE
approved drug
IDENTITY
Sequence verified

No structure asset recorded

TOP EVIDENCE
Grade B — Acute heart failure (hemodynamic and symptom improvement)
MAJOR STATUS
Jurisdiction-specific — see status table
SPORT
Prohibited — as of 2026-08-06
VERIFIED
2026-08-06

Bottom line

Carperitide is recombinant human atrial natriuretic peptide (hANP) approved only in Japan since 1995 for acute heart failure. It is not approved by FDA, EMA, or MHRA. The COMPASS study provided the largest evidence base. Availability is Japan-limited.

Identity and composition

FieldVerified information
Preferred nameCarperitide
Key aliasesHANP, alpha-hANP, Suntory brand, SUN-4936
Molecular/sequence identitySer-Leu-Arg-Arg-Ser-Ser-Cys-Phe-Gly-Gly-Arg-Met-Asp-Arg-Ile-Gly-Ala-Gln-Ser-Gly-Leu-Gly-Cys-Asn-Ser-Phe-Arg-Tyr (28 aa); disulfide bridge Cys7–Cys23
Modifications/formRecombinant (yeast); solution ()
Stable identifiersUNII: M6739UWY9H; : 16129708; CAS: 118812-69-4; DrugBank: DB04895
Identity caveatsJapan-limited approval. Identical in sequence to human ANP(1-28). Not interchangeable with nesiritide (BNP).

Development and approval status

JurisdictionStatus and indicationProduct/sourceAs of
Japan (PMDA)Approved: acute heart failure (since 1995)Carperitide (Daiichi Sankyo / Suntory)1995
US (FDA)Not approved2026
EU/EEA (EMA)Not approved2026
UK (MHRA)Not approved2026
Status is multi-axis
Carperitide authorization and sport-status profileFour medicine-authorization axes reproduce only documented status rows; sport status is shown separately.UNITED STATESNot approvedSOURCE / AS OFROW 2 / 2026EU/EEANot approvedSOURCE / AS OFROW 3 / 2026UNITED KINGDOMNot approvedSOURCE / AS OFROW 4 / 2026OTHER DOCUMENTEDApproved: acute heart failure(since 1995)SOURCE / AS OFROW 1 / 1995SPORT STATUS — SEPARATE FROM MEDICINE AUTHORIZATIONWADA: Not prohibited.
Authorization belongs to the named product, use, place, and date; sport status is independent.
文字说明
UNITED STATES
US (FDA): Not approved
EU/EEA
EU/EEA (EMA): Not approved
UNITED KINGDOM
UK (MHRA): Not approved
OTHER DOCUMENTED
Japan (PMDA): Approved: acute heart failure (since 1995)

Sport status: WADA: Not prohibited.

Mechanism and pharmacology

Natriuretic peptide receptor-A (NPR-A) agonist. Binding to NPR-A on vascular smooth muscle, kidney, and endothelium increases cGMP, promoting vasodilation, natriuresis, and RAAS suppression. Reduces preload and afterload in acute heart failure. ANP has slightly different receptor affinity profile from BNP (nesiritide).

Evidence by claim

Claim/indicationStageGradeBest human evidenceMain resultImportant limitations
Acute heart failure (hemodynamic and symptom improvement)Approved (Japan only)BCOMPASS (prospective registry, N=1,177); LASCAR-AHF (N=247, PMID 39656827)COMPASS: hemodynamic improvement; LASCAR-AHF: no reduction in mortality/HF hospitalization or dyspnea improvementCOMPASS is a registry, not a randomized comparative trial; LASCAR-AHF found no benefit on primary endpoints
证据等级
  • AA级:已确定特定标签用途
  • BB级:中等人体证据
  • CC级:初步人体证据
  • DD级:仅临床前
  • EE级:轶事/营销声明
  • XX级:证据与该声明相矛盾或不支持该声明
了解有关证据分级的更多信息
Claim-evidence profile
Carperitide claim-evidence profileA: 0 claims; B: 1 claim; C: 0 claims; D: 0 claims; E: 0 claims; X: 0 claimsCONTRADICTORY / NON-SUPPORTIVEA — Established for a specific labeled useGrade A: Established for a specific labeled use — current approval plus adequate controlled trials and post-market context.0 claimsB — Moderate human evidenceGrade B: Moderate human evidence — multiple controlled studies or a strong pivotal study, but no current approval for the claim.1 claimAcute heart failure (hemodynamic and…C — Preliminary human evidenceGrade C: Preliminary human evidence — small, uncontrolled, surrogate-endpoint, or early-phase studies.0 claimsD — Preclinical onlyGrade D: Preclinical only — in vitro or animal evidence with no adequate human efficacy evidence.0 claimsE — Anecdotal/marketing claimGrade E: Anecdotal/marketing claim — testimonials, extrapolation, or vendor claims without adequate scientific support.0 claimsX — Evidence contradicts or does not support the claimGrade X: Evidence contradicts or does not support the claim — adequate negative evidence, failed program, or claim inconsistent with the studied material.0 claims
This counts the page's claim rows; it does not average them into a score.
文字说明

Text alternative for the claim-evidence diagram. Each grade is defined below:

AEstablished for a specific labeled use
0 claims
BModerate human evidence
1 claim: Acute heart failure (hemodynamic and symptom improvement)
CPreliminary human evidence
0 claims
DPreclinical only
0 claims
EAnecdotal/marketing claim
0 claims
XEvidence contradicts or does not support the claim
0 claims
United StatesNot approved
EU/EEANot approved
United KingdomNot approved
OtherApproved: acute heart failure (since 1995)

Key studies

StudyDesign/populationExposure studiedEndpoints and resultLimitations
COMPASSJapanese prospective registry, ADHF (N=1,177)Carperitide vs standard careHemodynamic improvement, no mortality benefitRegistry design, not randomized; Japanese population only
Japanese Phase 3, N=100+, ADHFCarperitide 0.0125–0.05 mcg/kg/minImproved cardiac index, PCWP, dyspneaSmall sample; dated

Dose and administration evidence

Approved labeled regimen

The label summary below is product-, indication-, and jurisdiction-specific; consult the full current label and a licensed clinician/pharmacist.

Acute heart failure (Japan label): 0.0125–0.05 mcg/kg/min continuous infusion. No bolus dose. Higher rates may increase hypotension risk.

Studied regimens (not recommendations)

  • COMPASS: 0.0125–0.05 mcg/kg/min IV.

  • Other studies: 0.1 mcg/kg/min (associated with more hypotension).

What is not established

  • Mortality benefit not demonstrated.

  • Use outside Japan in controlled settings.

  • No established or recommended human dose for unapproved indications.

Safety

Established label risks

  • Hypotension: Dose-related; may require dose reduction or discontinuation.

  • Renal: Transient creatinine increase.

  • GI: Nausea.

  • Electrolyte: Hyperkalemia.

Human-study signals

  • No adequately powered mortality study completed.

Unknowns and product-quality risks

  • A Japanese authorization was identified; no FDA-approved product or EMA-authorized medicine was identified, and availability elsewhere requires a current national-register check.

  • No Good Manufacturing Practice assurance for non-Japanese sources.

  • Research-grade vials from non-Japanese sources are not audited by PMDA.

Interactions and special populations

  • Additive hypotension with other vasodilators.

  • ACE inhibitors may potentiate effect.

  • Renal impairment: adjust infusion rate.

Regulatory, compounding, and sport notes

  • : Not prohibited.

  • Not scheduled under US CSA.

  • The reviewed authorization is Japanese. This page makes no categorical claim about authorization or availability in every other jurisdiction.

Evidence gaps

Search notes

  • Databases and registries: PMDA (Japanese), PubMed, ClinicalTrials.gov

  • Search terms: carperitide, HANP, atrial natriuretic peptide, acute heart failure, Japan

  • Last searched: 2026-08-06

  • Inclusion emphasis: Japanese label, phase 3 trials, regulatory status

Sources

  1. PMDA. Carperitide (HANP) prescribing information. https://www.pmda.go.jp/

  2. PubChem. Carperitide. https://pubchem.ncbi.nlm.nih.gov/compound/16129708

  3. DrugBank. Carperitide. https://go.drugbank.com/drugs/DB04895

  4. Suwa M, et al. Carperitide for acute heart failure in Japan. Circ J. 2007;71(12):1880–5. PMID: 18037740.

专家观点

专家怎么说

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问题

Is carperitide FDA-approved?

No. Carperitide (HANP, recombinant human atrial natriuretic peptide) is approved only in Japan since 1995 for acute heart failure. It is not approved by FDA, EMA, or MHRA. Availability is Japan-limited, and no Good Manufacturing Practice assurance exists for non-Japanese sources.

What evidence supports carperitide for acute heart failure?

The COMPASS study was a Japanese prospective open-label registry (N=1,177) showing hemodynamic improvement but no mortality benefit. A more recent RCT, LASCAR-AHF (N=247, PMID 39656827), found no reduction in mortality, HF hospitalization, or dyspnea improvement. No adequately powered mortality study has been completed.

Is carperitide the same as nesiritide?

No. Carperitide is recombinant human atrial natriuretic peptide (ANP, 28 aa), while nesiritide is B-type natriuretic peptide (BNP). They are not interchangeable and have slightly different receptor affinity profiles.

What are carperitide's main safety signals?

Hypotension is the primary treatment-related risk and can require clinicians to modify or stop treatment under the label. Other reported risks include transient creatinine increase, nausea, and hyperkalemia. No adequately powered mortality study has been completed, so a mortality benefit has not been demonstrated.

Is carperitide prohibited in sport?

No. Carperitide is not prohibited by WADA according to the 2026 Prohibited List. It is also not scheduled under the US Controlled Substances Act. The reviewed authorization is Japanese only.

What are the main evidence gaps for carperitide?

No mortality benefit has been demonstrated. No contemporary placebo-controlled trial outside Japan exists, and there is no comparison to standard of care (nesiritide, nitroglycerin) in Western populations.

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