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HCXT-2001_Dosage, benefits & legal status

Also known as HCXT2001

Published October 25, 2026

The clearest example on this site of a price tag arriving before any evidence.

Calm gut inflammationIL-23 receptor antagonist (oral macrocyclic peptide)Investigational
DoseNo human dose disclosed
FrequencyNot disclosed
RouteBy mouth, in trials only
StatusInvestigational
CycledNot established

Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.

See how this dose compares across the library →

01

What is HCXT-2001?

Plain language first. The technical label stays, but it never stands alone.

Overview

This is a pill-form peptide aimed at the same target as icotrokinra, the approved psoriasis drug on this site. The difference is the evidence. Icotrokinra has four published phase 3 programs behind it. HCXT-2001 has a billion-dollar purchase price and a phase 1 program with nothing published at all. A large company paying a large sum tells you what that company believes about a molecule's future. It tells you nothing about whether the molecule works, because the people who sold it and the people who bought it have both seen data that nobody else has.

The technical version

HCXT-2001 is an investigational oral macrocyclic peptide inhibitor of the interleukin-23 receptor, originated by PepStar Therapeutics Limited of Shanghai. Gilead Sciences announced on October 22, 2026 that it had agreed to acquire the program for $1.275 billion in upfront cash, with closing expected in the fourth quarter of 2026. Gilead describes the molecule as having an extended half-life and names inflammatory bowel disease as the lead indication, with psoriasis as a possible application. No sequence, structure, residue count, dose or trial result has been disclosed.

What it's used for

Nothing. It is an investigational oral peptide in phase 1 testing for inflammatory bowel disease, with psoriasis named as a possible later use.

02

How does HCXT-2001 work?

What it does in the body, and where.

Interleukin-23 drives several inflammatory diseases, and blocking its receptor already works: the approved antibodies do it by injection, and icotrokinra does it with a peptide taken by mouth. The open question for this class is not whether the target is right. It is how to get a peptide through the gut.

  1. 01
    Why an oral peptide is hard
    Peptides are food as far as the digestive tract is concerned. Stomach acid and gut enzymes break most of them apart before they reach the bloodstream, and that is why nearly every peptide on this site is injected. Getting one to survive the trip and still bind its target is the whole engineering problem.
  2. 02
    What macrocyclic means here
    A macrocycle is a peptide joined into a ring rather than left as a loose chain. The ring leaves fewer loose ends for enzymes to attack and holds the molecule in a fixed shape, so a well-designed one can survive the gut and still fit its receptor. Gilead also credits this molecule with an extended half-life, without saying what it is.
  3. 03
    What is actually known about this one
    The target, the route, the chemical class and the lead disease. That is the complete list. No sequence, no residue count, no potency figure, no dose, no trial result and no registry record we could open. Everything else written about HCXT-2001 is about the transaction rather than the molecule.
Anatomical illustration highlighting the whole body
WHAT THIS COMPOUND ACTS ON:
03

What else is it used for?

Each group carries its own evidence level.

Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.

What has been published

Investigational
  • No dataNothing. There is no published trial result, no disclosed dose, no sequence and no potency figure for HCXT-2001 anywhere we could find, including in the announcement that valued it at $1.275 billion upfront.
  • RegulatoryGilead's release names the chemical class, the target, the route, the lead indication and the phase. Those five facts are the extent of the public record on the molecule itself.
  • No dataTrade reporting describes trial registrations on China's registry and in New Zealand. We could not open those records: the ClinicalTrials.gov search endpoints refused our queries, and the single Australian and New Zealand registry record our search returned was an unrelated oral insulin trial. So the existence of those studies rests on reporting rather than on a registry page we read.

The comparison worth making

FDA-approved
  • RegulatoryIcotrokinra, sold as Icotyde, reaches the same receptor as an oral peptide and is already approved: by the FDA on March 17, 2026 under NDA 220149 and in the European Union on September 18, 2026. Behind it sit ICONIC-LEAD, ICONIC-ADVANCE 1 and 2, ICONIC-TOTAL and FRONTIER 1.
  • No dataThat is what a finished evidence package for this target and this route looks like. HCXT-2001 is at the opposite end of the same road, and the gap between them is the reason to be careful with anything written about it.
  • No dataThe two are not interchangeable and not competitors in any sense a reader can act on. One is a prescription medicine with published trials; the other is a phase 1 asset that changed owners.
Often left out

A $1.275 billion upfront payment is the most quotable fact about HCXT-2001 and the least informative. It reflects what Gilead believes about a molecule whose data only the buyer and the seller have seen, and it is not a result. Expect to see the figure used as though it were one. The second error is treating this as a rival to icotrokinra that a reader might choose between: icotrokinra is approved and prescribed, and HCXT-2001 is in phase 1 with nothing published. The third is the word peptide doing more work than it should. This is an engineered macrocycle built to survive the stomach, and it has nothing in common with the injectable research peptides on the rest of this site beyond the chemical category.

The published record

Research index

1

Papers and trials about HCXT-2001

Searched: HCXT-2001, HCXT2001.

Left out: IL-23R inhibitor (a class term shared with icotrokinra and the injectable antibodies, each with its own slug or none); oral peptide (a delivery descriptor matching hundreds of unrelated papers); PepStar (a company name, which returns corporate and transaction coverage rather than science); macrocyclic peptide (a chemical class with a large medicinal-chemistry literature unrelated to this molecule).

1 papers tagged human · 0 not reviews or lab · 0 clinical trial publications

1 registered trials · none with posted results

Furthest stage reached: Phase 1, not yet recruiting

Compare this against the whole library →

In animals0
In the lab0
Reviews0
Senior author shareSpread across many groups

Evidence summary

Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.

HCXT-2001 vial rendering
Compound field notes

At a glance

Four things to know about HCXT-2001

01

Evidence

Investigational

02

Category

Immune support

03

Common vial

Varies

04

Half-life

Not disclosed

04

How much, and do you cycle it?

The range, and whether you take breaks.

No human dose disclosed, not disclosed. Not established No range

No dose or schedule has been disclosed. Whether it is taken daily or weekly is reported as an open question inside the first trial's design.

Compare this against the whole library →

05

How long does it stay in the body?

The half-life, and where the figure comes from.

Not disclosedNo figure

Gilead calls it an extended half-life and gives no figure, and trade reporting says PepStar engineered the extension. No number has been published, so none is quoted here. Whether the drug ends up taken daily or weekly is reported as an open question inside the first trial.

You can compare this against the whole library to see where it sits.

06

What does it cost?

Typical dose and cost, in plain numbers.

HCXT-2001 is not injected in the forms covered here

It is taken by mouth, in trials only. No dose has been disclosed. Trade reporting suggests the multiple-dose stage of the first trial may compare daily with weekly dosing, and that is a report about a trial design rather than a dose. Any figure offered as an HCXT-2001 dose would be invented.

Cost per month
—
Cost per dose
—
Typical dose
—No range
07

How do you store it?

Before mixing, and after.

Nothing to store: it is not sold anywhere.

HCXT-2001 has never been marketed, so there is no vial, pen or bottle to keep at home. Supplies for a trial are made, stored and dispensed by the sponsor and the trial pharmacy under conditions set in the protocol. Anything offered for sale under this name did not come from that supply chain.

08

What are the side effects and cautions?

Known cautions and warnings for this compound.

Who should avoid it

Check these before anything else.
  • Any use outside a trial: no product exists, no dose has been disclosed and no safety data have been published
  • Anything offered for sale under this name: no structure has ever been released, so a sample cannot be checked against a reference
  • Reading the purchase price as evidence of effect

Stop and get help

These are emergencies. Seek care.
  • Not applicable outside a trial

Common effects

Expected, and usually mild.
  • Unknown. No human data of any kind have been published

Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.

09

Is HCXT-2001 approved?

And where the numbers on this page come from.

No. HCXT-2001 is not approved anywhere and is currently in company-run clinical trials. There is no legal route to obtain it outside a trial.

What has happened recently

Not approved anywhere, and no clinical result has been published. Gilead Sciences announced on October 22, 2026 an agreement to acquire the oral IL-23 receptor inhibitor program, lead asset HCXT-2001, from PepStar Therapeutics Limited for $1.275 billion in upfront cash payable at closing, with closing expected in the fourth quarter of 2026. The release states the molecule is in phase 1 and gives no trial identifier and no data. Trade reporting places PepStar in Shanghai, describes two food-effect studies in healthy volunteers added to China's clinical trial registry in August and September 2026, and a third study of HCXT-2001 tablets in healthy adults in New Zealand, and says the first phase 1 trial could test daily and weekly dosing in its multiple-ascending-dose stage. We could not confirm those registrations ourselves: the ClinicalTrials.gov search endpoints refused our queries, and the one Australian and New Zealand registry record our search surfaced turned out to be an unrelated oral insulin study. No FDA substance record, International Nonproprietary Name or CAS number was located.

Guides for this compound

Sources

  • Gilead Sciences, agreement to acquire the investigational oral IL-23R inhibitor HCXT-2001, October 22, 2026(2026)
    The primary source for everything on this page. Describes HCXT-2001 as an investigational oral macrocyclic peptide inhibitor of IL-23R with an extended half-life, acquired from PepStar Therapeutics Limited, a privately held clinical-stage biotechnology company, for $1.275 billion in upfront cash consideration payable at closing, with closing expected in the fourth quarter of 2026. Names inflammatory bowel disease as the lead setting and psoriasis as a potential application, and states the asset is currently in phase 1 clinical trials. Gives no trial identifier and no efficacy or safety data. States that its safety and efficacy have not been established and that it has not been approved by any regulatory authority.
  • Fierce Biotech coverage of the Gilead and PepStar agreement(2026)
    Trade reporting rather than a primary document, and the source of the registry and dosing detail on this page. Places PepStar in Shanghai, states that PepStar extended the molecule's half-life, and reports two healthy-volunteer food-effect studies on China's clinical trial registry added in August and September plus a third study of HCXT-2001 tablets in healthy adults in New Zealand. Says the first phase 1 trial could test daily and weekly administration in its multiple-ascending-dose stage. Notes that patients taking the approved comparator must wait at least 30 minutes before eating. Reports no clinical data for HCXT-2001.

Beyond these, 1 records are indexed. Browse the records