TheraRadar

Emerging Drugs

Phase 3 programs against molecular targets with no FDA-approved drug.

Updated 2026-04-28 · 18 drugs · See methodology

Where first-in-class drugs come from.

A target without an approved drug is a hypothesis. The day a Phase 3 trial reads out positive, the hypothesis becomes a market — deal multiples, competitive maps, pricing benchmarks all snap into place at once. Lumakras did that for KRAS-G12C in 2021. Pyrukynd did it for PKLR in 2022. Sotyktu did it for TYK2 the same year. The drugs on this page are sitting in the same pre-readout state today, against targets that have not yet been priced.

This is the 18-drug list: industry-sponsored Phase 3 programs targeting a molecule with no FDA-approved drug as of 2026-04-28. TL1A — six sponsors, three megadeals, ~$18B committed before any Phase 3 readout — is the most-cited recent example. The rest are spread across inflammation, cardiometabolic, oncology, and rare disease.

Inclusion: registered industry-sponsored Phase 3 + target unapproved at 2026-04-28 + trial activity in the last three years + manual verification against ClinicalTrials.gov, FDA filings, and public BD disclosures. Excluded: failed programs (Magrolimab/CD47, Idasanutlin/MDM2); false positives where the target is approved under another name (Etavopivat/PKLR — mitapivat is already Pyrukynd).

Each drug links to a profile with the full Phase 3 trial roster (NCT IDs, enrollment, status, primary completion dates), BD history with deal values, the competitive landscape at that target, and the open scientific questions for that program. Trial data refreshes weekly from the ClinicalTrials.gov v2 API; deal history is curated by hand. Full methodology.

Methodology scorecard
18 drugs tracked
5 won — positive Ph3 readout / NDA path
0 lost — Ph3 missed / program scrapped
3 mixed
10 pending

Resolved drugs are kept on the list — wins are proof of methodology; losses are cautionary tales. Sorted to bottom; pending drugs (where the bet is still open) are at the top.

18
Emerging drugs
69
Distinct P3 trials
14
Industry sponsors
11
Tracked BD deals
Drug Target Sponsor P3 Status
Tulisokibart
MK-7240 / PRA023
TNFSF15
Blocker
Merck Sharp & Dohme LLC 3 P3 active
Afimkibart
RVT-3101 / PRA023
TNFSF15
Blocker
Hoffmann-La Roche 6 Active P3 program
16 more emerging drugs · TIGIT, OX40, CD40L, BAFF-R, CYP11B2, Lp(a), MDM2, FXIa, AGT, and 7 more
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How this list was built

We start from the TheraRadar atomic trial table (193K rows of trial × target × sponsor) joined with FDA-approved drug records. We filter to industry-sponsored Phase 3 trials targeting molecules with no FDA approval as of 2026-04-28, and manually verify each candidate against ClinicalTrials.gov, FDA filings, and public BD disclosures.

We exclude failed-program drugs (e.g., Magrolimab/CD47 — Gilead terminated all P3s 2023; Idasanutlin/MDM2 — Roche walked away) and drugs against targets that turn out to be approved under different naming conventions (e.g., Etavopivat/PKLR — mitapivat already approved as Pyrukynd).

Trials data updated weekly from ClinicalTrials.gov v2 API; BD deal context curated by hand. See full methodology.