Asset profile

HiCM-188 (allogeneic iPSC-cardiomyocytes)

Cell therapy

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Phase 3underway

Evidence outlook · registrational

Heart Failure: registrational readout pending

Entered Phase 3 on partial signal mid-stage evidence. Registrational readout expected around 2027-06-30.

HEAL-CHF (NCT03763136): The trial randomized 20 participants to hPSC-CM therapy or a sham comparator consisting of coronary artery bypass surgery alone, with outcome assessors masked to treatment assignment. Its primary endpoints were clinical safety outcomes, but results are not posted and the small sample limits the strength of the evidence.

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Competitive landscape

68 competitors in this universe: 8 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 17 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
HiCM-188 (allogeneic iPSC-Cardiomyocytes): this drugPhase 3Cell therapyCardiac cell therapy
CardiAMPPhase 3Cell therapyCardiac cell therapy
Deramiocel (CAP-1002)Phase 3Cell therapyCardiac cell therapy
ADR-002KPhase 2Cell therapyCardiac cell therapy
HS-001Phase 1/2Cell therapyCardiac cell therapy
HucMSC Intramyocardial TherapyPhase 1/2Cell therapyCardiac cell therapy
Anhui HygeianCells EE001Phase 1Biologic (subtype unspecified)Cardiac cell therapy
iPSC-CLPhase 1Cell therapyCardiac cell therapy
STM01Phase 1Cell therapyCardiac cell therapy
Baxdrostat (Baxfendy)ApprovedSmall moleculeAldosterone synthase (CYP11B2)
Dapagliflozin (Farxiga / Forxiga)ApprovedSmall moleculeSGLT2
Empagliflozin (Jardiance)ApprovedSmall moleculeSGLT2
Ferric Carboxymaltose (Injectafer / Ferinject)ApprovedIron Complex (iv)Iron repletion
Ferric Derisomaltose (Monoferric / Monofer)ApprovedIron Complex (iv)Iron repletion
Finerenone (Kerendia)ApprovedSmall moleculeMineralocorticoid receptor
Furosemide (subcutaneous, scPharmaceuticals) (FUROSCIX)ApprovedSmall moleculeNKCC2

…and 53 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Compare head-to-head

2 further head-to-head pairs are tracked; the rosters on each shared mechanism and indication page list every rival in the race.

Upcoming events

(4 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (1)
November 2026 (1)
Phase 1/2Heart FailureActive not recruiting
Est. primary completion 2026-11-10 · NCT06340048 · CT.gov ↗
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2027 (1)
June 2027 (1)
Phase 3Heart FailureRecruiting
Est. primary completion 2027-06-30 · NCT07496372 · CT.gov ↗
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2028 (2)
May 2028 (1)
Phase 1/2Heart FailureNot yet recruiting
Est. primary completion 2028-05 · NCT07646210 · CT.gov ↗
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October 2028 (1)
Phase 1/2Heart FailureNot yet recruiting
Est. primary completion 2028-10-20 · NCT07471698 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (1)
Phase 1/2 (5)
Phase 1 (1)
Appears in other studies (2)