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Drug Pipeline Review Therapy area: Acne40–50 pages · PDF + Excel tracker

Acne Drug Pipeline: 12 Assets by Phase

Acne pipeline: 12 drug candidates in clinical development, 4 in Phase III, from 12 sponsors. Data as of 3 Oct 2026.

Pipeline Terminal Acne Data as of 3 Oct 2026
Candidates in development 12assets Desk-reviewed How this number is madeEvery drug named in an interventional trial, merged across code, generic and brand names, with a live or recent industry trial. Placebo and comparator arms excluded.
Phase III 433% of pipeline Registry How this number is madeCandidates whose highest phase in a live or recent trial is Phase III (Phase II/III counts as Phase II).
Phase II 542% of pipeline Registry
Phase I 325% of pipeline Registry
Sponsors 12top 5 hold 42% Registry How this number is madeCompanies credited with at least one candidate: the lead sponsor on most of that candidate's industry trials.
Registered trials 25260 running Registry How this number is madeInterventional trials on ClinicalTrials.gov for the conditions in scope, updated since 3 Oct 2021.
Readouts in 12 months 4Phase II or later Sponsor dates How this number is madeCandidates with a registered primary completion date in the next 12 months. Dates are the sponsor's own and often move.
Trials with US sites 12449% · Europe 15% Registry How this number is madeTrials with at least one site in the United States; Europe is the EU/EEA, the UK and Switzerland. A trial counts in every region where it has a site.

Candidates by highest phase reached

Phase I3
Phase II5
Phase III4

Next registered primary completions, Phase II or later

CandidatePhasePrimary completion
ClascoteronePhase IIIOct 2026 (est.)
KR230109 creamPhase IIOct 2026 (est.)
TrifarotenePhase IIIDec 2026 (est.)

Candidates in development by lead sponsor

Biofrontera Inc.1
Sanofi Pasteur, a Sanofi Company1
Ascletis Pharmaceuticals Co., Ltd.1
Bluefin Biomedicine, Inc.1
Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.1

Phase II and III primary completions per quarter

Q4 20263
Q1 20270
Q2 20270
Q3 20271
Q4 20270
Q1 20280
Q2 20280
Q3 20281

Answers at a glance

  • 4 of 12 acne candidates (33%) are in Phase III.
  • Biofrontera Inc. runs the largest acne pipeline, with 1 candidates.
  • 4 readouts are due in 12 months; the next is Clascoterone in Oct 2026.
  • 21 trials are recruiting patients now; 49% of all trials have a US site and 15% a European one.
12 candidates252 trials54 countriesData as of 3 Oct 2026Next refresh by 1 Jan 2027
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Edition: data as of 3 Oct 2026 Next refresh: by 1 Jan 2027 Change: First edition

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A sample of the Acne Pipeline Review: the full chapter list, the tracker columns and two asset profiles from the report. The Research Desk reviews your request and emails it, usually within one business day.

Acne has 12 drug candidates in active clinical development, of which 4 are in Phase III, 5 in Phase II and 3 in Phase I, according to Douglas Insights' count of 252 interventional trials registered on ClinicalTrials.gov (data as of 3 Oct 2026).

The acne drug pipeline is the set of medicines that sponsors are still testing in people for this condition: each candidate is counted once, at the highest phase it has reached in a running or recently completed trial. Medicines already on the market and studied only in Phase IV trials are kept out of the count.

How many acne drugs are in each phase of development?

Douglas Insights counts 4 acne candidates in Phase III, 33% of the 12 assets in development; Phase II holds 5 and Phase I holds 3.

Phase I3Phase II5Phase III4
Candidates by highest phase reached. Source: Douglas Insights from ClinicalTrials.gov, data as of 3 Oct 2026.
Phase (highest reached)AssetsShare of pipeline
Phase III433%
Phase II542%
Phase I325%
Total12100%

Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each acne asset appears in exactly one row. The 60 trials still recruiting or running carry 24% of the 252 registered trials in scope.

Which approved acne medicines are still in trials?

5 medicines already on the market are still being tested in acne Phase IV trials; Isotretinoin has the most, with 28 registered trials.

MedicineLead sponsorRegistered trials
IsotretinoinGalderma R&D28
DoxycyclineGalderma R&D9
IDP-126Bausch Health Americas, Inc.5
Winlevi creamSun Pharmaceutical Industries Limited4
SarecyclineIntegrative Skin Science and Research1

Post-approval acne trials test new doses, new patient groups and head-to-head comparisons. They set the standard of care that every candidate in development will be measured against, so the paid review profiles each one.

How many acne trials are recruiting patients now?

21 acne trials are recruiting patients and 22 more have not started recruiting yet, out of 252 interventional trials in scope; together they make up 17% of the trial base.

Registry statusTrialsShare
Completed15260%
Status not verified3012%
Not yet recruiting228.7%
Recruiting218.3%
Active, not recruiting176.7%
Terminated62.4%
Withdrawn31.2%
Suspended10.4%

Terminated, suspended and withdrawn acne trials stay in the trial base so that a stalled programme is visible, but a candidate whose only trials stopped is no longer counted as in development.

Which companies lead the acne pipeline?

Biofrontera Inc. leads the acne pipeline with 1 candidates; the top 5 sponsors hold 42% of the 12 assets, and 12 sponsors run at least one.

SponsorAssets in developmentShare
Biofrontera Inc.18.3%
Sanofi Pasteur, a Sanofi Company18.3%
Ascletis Pharmaceuticals Co., Ltd.18.3%
Bluefin Biomedicine, Inc.18.3%
Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.18.3%

Industry sponsors lead 123 of the 252 acne trials (49%); universities, hospitals and public funders lead the rest. A sponsor is credited with an asset when it is the lead sponsor on most of that asset's industry trials.

Which drug types and mechanisms dominate the acne pipeline?

Mechanism and drug-type classification for the 12 acne candidates is done by the research desk asset by asset, each with a cited source, and is published in the paid review together with the white-space map.

What acne trial readouts are coming next?

4 acne candidates in Phase II or later have a registered primary completion date in the next 12 months; the next three are below, each linked to its registry record.

CandidateSponsorPhasePrimary completionRegistry
ClascoteroneZhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.Phase IIIOct 2026 (estimated)NCT06403501
KR230109 creamJiangxi Kvvit Pharmaceutical Co., Ltd.Phase IIOct 2026 (estimated)NCT07345390
TrifaroteneGalderma R&DPhase IIIDec 2026 (estimated)NCT07186413

Primary completion is the date a sponsor expects the last patient to finish the main measurement, so data usually follow within months. Dates marked estimated are the sponsor's own forecast on the registry and often move.

How many acne readouts fall in each quarter?

5 acne candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 3, due in Q4 2026.

QuarterPhase III readoutsPhase II readoutsTotal
Q4 2026213
Q1 2027000
Q2 2027000
Q3 2027011
Q4 2027000
Q1 2028000
Q2 2028000
Q3 2028011

Each candidate is counted once, at its next readout. The paid catalyst calendar names every readout with its trial, sponsor and design, adds filings and regulatory decisions, and runs 24 months ahead.

Which countries host the most acne trials?

United States hosts the most acne trials, with sites in 124 of the 252 studies (49%); trials in scope run in 54 countries in all.

CountryTrials with a siteShare of trials
United States12449%
Canada3112%
Egypt249.5%
France228.7%
Germany228.7%
Spain207.9%
China197.5%
Poland197.5%

A multinational acne trial is counted once in every country where it has a site, so the shares add up to more than 100%. Country spread shows where sponsors are building the evidence that regulators in each market will ask for.

Where are acne drugs being tested?

124 of the 252 acne trials (49%) have a site in the United States, 39 (15%) in Europe and 19 (7.5%) in China; 7 of the 12 candidates in development are tested in the US.

RegionTrials with a siteShare of trialsCandidates testedRegulator
United States12449%7FDA
Europe (EU/EEA, UK, Switzerland)3915%2EMA, MHRA, Swissmedic
China197.5%4NMPA
Japan72.8%0PMDA
Rest of world10140%4national regulators

Each region's trials are the evidence its regulator will review: the FDA in the United States, the EMA (with the MHRA and Swissmedic) in Europe, the NMPA in China and the PMDA in Japan. A multinational acne trial counts once in every region where it has a site, so the shares add up to more than 100%. A candidate tested only outside the US and Europe is often a licensing opportunity for sponsors in those markets.

What has changed in the acne pipeline since the last update?

This is the first edition of the acne pipeline count, dated 3 Oct 2026. The next refresh is due by 1 Jan 2027, and each refresh lists the assets that entered, advanced or dropped out.

How does Douglas Insights count the acne pipeline?

Douglas Insights read 252 interventional trials registered on ClinicalTrials.gov for the conditions "Acne Vulgaris", "Acne" and updated since 3 Oct 2021, then grouped every drug or biologic named in them into 12 unique candidates.

  1. Code names, generic names and brand names of the same molecule are merged into one candidate, and every merge is reviewed by the research desk.
  2. A candidate counts when it has a trial that is recruiting, running, or completed in the last 24 months, and at least one industry-sponsored trial.
  3. Its phase is the highest phase among those trials; placebo, standard-of-care and comparator arms are not candidates.
  4. Each figure on this page is drawn from one frozen dataset that passes ten checks before release, and the owner approves every edition.

Read the full approach on the research methodology page, or browse other Pharmaceuticals research.

What does the Acne Pipeline Review include?

The Acne Pipeline Review covers all 12 candidates in an Excel tracker and profiles the leading 12 in a 40–50 page report, ending with the research desk's ranked view of the candidates most likely to win.

11 chapters40–50 pages25 asset profilesExcel tracker of all 12 candidates
01Executive summary and our call2–3 pp

The pipeline on one page and the desk's verdict on where acne treatment is heading.

  • Pipeline size and phase mix
  • The three calls that matter
  • What changed since the last edition
02Disease and unmet need3 pp

Who is treated today, what current therapy leaves unmet, and how regulators judge new medicines.

  • Patient population and diagnosis
  • Treatment guidelines and gaps
  • Regulatory endpoints
03Approved therapies3 pp

The marketed medicines every acne candidate will be measured against.

  • Marketed medicines and their sponsors
  • Post-approval trials
  • The bar a new entrant must clear
04Pipeline at a glance4 pp

Every candidate counted by phase, drug type, sponsor and country.

  • Assets by phase and drug type
  • Sponsors by size of pipeline
  • Trial footprint: US, Europe, China, Japan
05Mechanism landscape and white space5 pp

Which mechanisms are crowded and which no sponsor has entered.

  • Mechanism classes and crowding
  • Classes with no candidate yet
  • Differentiation by route and dosing
06Key asset profiles12–15 pp

The leading 25 candidates, one profile each, every claim linked to a source document.

  • Design and endpoints of the pivotal trials
  • Data to date, with sources
  • Next readout and the risk to it
07Catalyst calendar3 pp

Readouts, filings and regulatory decisions 24 months ahead.

  • Readouts by quarter
  • Filings and regulatory decisions
  • Date confidence for each event
08Deals and partnering3 pp

Who is licensing, buying and partnering in acne, and on what terms.

  • Licensing and M&A in the area
  • Deal terms where disclosed
  • Sponsors open to partnering
09Sponsor landscape3 pp

Large pharma against biotech, and how concentrated the pipeline is.

  • Pipeline share by sponsor
  • Sponsor-by-phase matrix
  • New entrants since the last edition
10Our call: winners, risks, opportunities3–4 pp

The candidates most likely to win, ranked, with the reasoning and evidence.

  • Ranked candidates
  • Risks that could change the order
  • Openings for new entrants and investors
11Methodology and source log2 pp

How the count is built and every document behind it.

  • How candidates are counted and merged
  • Every source document listed
  • The ten quality checks

Ways to buy the Acne review

OptionWhat you getDeliveryPrice
Pipeline SnapshotThis therapy area as published: PDF report + Excel trackerReady nowUSD 3,000Enquire
Pipeline ReviewYour indication, geography and phase cut-off; ranked calls and an analyst call2–3 weeksFrom USD 4,000Enquire
Company AssessmentOne sponsor's full pipeline against its peers2 weeksFrom USD 5,000Enquire

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Frequently asked questions about the acne pipeline

How many drugs are in the acne pipeline?

12 drug candidates are in active clinical development for acne, with 4 in Phase III, per Douglas Insights (data as of 3 Oct 2026).

Which company has the most acne drugs in development?

1 candidates make Biofrontera Inc. the largest acne pipeline sponsor, out of 12 sponsors counted by Douglas Insights.

When is the next acne trial readout?

Oct 2026 is the registered primary completion of the Phase III trial of Clascoterone (NCT06403501), the next acne catalyst in Douglas Insights' calendar.

How many acne trials run in the United States and Europe?

124 acne trials have a US site and 39 a European site, out of 252 registered trials counted by Douglas Insights (data as of 3 Oct 2026).

How often is the acne pipeline count updated?

90 days is the refresh cycle; this edition uses registry data as of 3 Oct 2026 and the next is due by 1 Jan 2027.

Research & citation

This review was researched, written and reviewed by the Douglas Insights Research Desk under the Douglas Insights editorial standards. Material errors are logged in the corrections log. No section is sponsored.

Cite this page Douglas Insights (2026). Acne Drug Pipeline, data as of 3 Oct 2026. https://www.douglasinsights.com/pipeline/acne/