ABS-201
An antibody treatment given by injection that is designed to block the prolactin receptor.
- Used or studied for
- Androgenetic alopecia
- How it works
- Prolactin receptor blockade
- Developer or manufacturer
- Absci Corporation
- Sources last checked
- September 19, 2026
Overview
ABS-201 is an experimental antibody from Absci designed to block the prolactin receptor. It targets the same receptor as HMI-115 but is a separate product from a different company. Absci describes it as engineered with its generative AI platform. See the sourced sections for what has been reported and its limits.
Regulatory status by country
Approval depends on the country and the condition. United States is shown first.
United States
Your countryU.S. Food and Drug Administration (FDA)
For: Androgenetic alopecia
Not yet verifiedWe have not yet verified this. Do not rely on it.
We have not checked the regulatory position of ABS-201 in the United States.
No source: this has not been checked.
Australia
Therapeutic Goods Administration (TGA)
For: Androgenetic alopecia
InvestigationalBeing studied in clinical trials. Not approved.
The trial registry lists a Phase 1/Phase 2 study with an Australian site as recruiting.
Source
Trial registryClinicalTrials.gov record NCT07317544: ABS-201 single and multiple ascending doses in adults with and without androgenetic alopecia(opens in a new tab)· Checked September 19, 2026
Evidence
The kind of evidence that exists. It is not a recommendation.
For: Androgenetic alopecia
Early human studiesWhat this means: Only small, early-phase or uncontrolled human studies have been reported. This describes the kind of evidence, not how well the treatment works or whether it suits anyone. About this scale
Early interim results from a first-in-human study have been announced by the developer; they cover safety and pharmacokinetics rather than hair growth.
Source
Company announcementNot peer-reviewedAbsci announcement, 24 June 2026: interim Phase 1 data from the HEADLINE study of ABS-201(opens in a new tab)
How it works
- Prolactin receptor blockade. Blocks the receptor for prolactin, a hormone whose role in hair growth is being explored.
Absci describes ABS-201 as an investigational anti-prolactin receptor (PRLR) antibody engineered with its generative AI platform.
Source
Company announcementNot peer-reviewedAbsci announcement, 4 December 2025: first participants dosed in the HEADLINE study of ABS-201(opens in a new tab)· Checked September 19, 2026
Development timeline
Where development has got to, as reported in sources. Reported events are events that have already happened; any sponsor expectation of what's next is shown separately and is never a confirmed date.
For Androgenetic alopecia · Sponsor: Absci Corporation (trial sponsor listed as Absci Pty Ltd.)
- PreclinicalReached
- Phase ILatest reported
- Phase IINot reached
- Phase IIINot reached
- Regulatory submissionNot reached
- ApprovalNot reached
- Market availabilityNot reached
The stage shown is the latest reported in sources. It does not predict whether or when later stages will happen.
Reported events
Trial startedPhase I
Sponsor announced first participants dosed in the HEADLINE study
Source
Company announcementNot peer-reviewedAbsci announcement, 4 December 2025: first participants dosed in the HEADLINE study of ABS-201(opens in a new tab)· Checked September 19, 2026
Results reportedPhase I
Sponsor announced interim data from the single-ascending-dose part of the study
The data cover safety and pharmacokinetics in healthy volunteers; no hair-growth results were reported.
Source
Company announcementNot peer-reviewedAbsci announcement, 24 June 2026: interim Phase 1 data from the HEADLINE study of ABS-201(opens in a new tab)· Checked September 19, 2026
Trials and reported results
How to read reported results
Results marked Sponsor-reported come from a company announcement or conference abstract. They have not been through independent peer review, may be selective, and are shown with their limitations. Peer-reviewed papers are labelled separately.
Registered trials
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
ClinicalTrials.gov NCT07317544(opens in a new tab) · Phase 1/Phase 2 · Sponsor: Absci Pty Ltd.
Registry status: Recruiting (checked September 19, 2026)
Reported results
- Safety or pharmacokinetics onlySponsor-reported
Sponsor reported interim safety and pharmacokinetic data from single-ascending-dose cohorts
Registered study: NCT07317544 (opens in a new tab) · Phase 1/Phase 2
The announcement covers data from 32 healthy adult participants in the single-ascending-dose (SAD) cohorts, in which participants were randomised 3:1 to ABS-201 or matched placebo. It reports that, in blinded aggregate interim data, the study drug appeared well tolerated, that no serious adverse events were reported as of the data cutoff, and that all treatment-emergent adverse events were mild except for a single moderate event. One case of headache (SAD 3 cohort) was assessed as unlikely to be related to study treatment. From interim pharmacokinetic data across the four SAD cohorts, the half-life of ABS-201 is estimated to be at least 65 days. No apparent impact of anti-drug antibodies on pharmacokinetics was observed. The announcement also states that the first multiple-ascending-dose cohort, in participants with androgenetic alopecia, has been initiated.
Limitations
Sponsor announcement of interim data, not peer-reviewed. The data come from healthy volunteers in the single-ascending-dose part of the study, are blinded and interim, and contain no hair-growth results. Hair-growth (efficacy) results have not been reported.
Source
Company announcementNot peer-reviewedAbsci announcement, 24 June 2026: interim Phase 1 data from the HEADLINE study of ABS-201(opens in a new tab)· Checked September 19, 2026
Sources
Every document this entry relies on, and the date we last read it.
- Trial registryClinicalTrials.gov record NCT07317544: ABS-201 single and multiple ascending doses in adults with and without androgenetic alopecia(opens in a new tab)
ClinicalTrials.gov (U.S. National Library of Medicine) · NCT07317544
Read on September 19, 2026
Registry wording as at the access date.
- Company announcementNot peer-reviewedAbsci announcement, 24 June 2026: interim Phase 1 data from the HEADLINE study of ABS-201(opens in a new tab)
Absci Corporation · Published June 24, 2026
Read on September 19, 2026
Sponsor announcement of interim data, not peer-reviewed.
- Company announcementNot peer-reviewedAbsci announcement, 4 December 2025: first participants dosed in the HEADLINE study of ABS-201(opens in a new tab)
Absci Corporation · Published December 4, 2025
Read on September 19, 2026
Sponsor announcement, not peer-reviewed.
