Company
Insilico Medicine
Scores have not been assigned.
Source Summary
6 reviewed sources across 3 source categories.
- Trial registries3
- Company filings / disclosures2
- Original scientific reports1
Company Snapshot
Event dates and registry update dates remain distinct.
Executive Summary
Insilico Medicine combines AI-based discovery with therapeutic development. Its rentosertib program targets TNIK in idiopathic pulmonary fibrosis. The listed company, InSilico Medicine Cayman TopCo, and the trial sponsor, InSilico Medicine Hong Kong Limited, have different legal roles.
Why It Matters
Readers can now inspect a published randomized study, separate US regulatory-history disclosure and a larger trial protocol. These sources do not establish longer survival, reversal of human aging or general superiority of AI-discovered drugs. The next important evidence is longer controlled efficacy and safety follow-up, including careful assessment of liver-related findings.
Platform / Pipeline Overview
| Program | Mechanism / pathway | Stage / status | Source type | Evidence boundary | Caution note |
|---|---|---|---|---|---|
| Rentosertib (ISM001-055 / INS018_055) | TNIK inhibition | Phase 3 recruiting label posted 13 October 2026 | Issuer filing / disclosure / Issuer prospectus / Original scientific article / Sponsor-submitted trial registry | Phase 2a had primary safety and secondary lung-function endpoints; liver-toxicity and diarrhea withdrawals were reported. | US hold/lift history remains issuer-attributed. Phase 3 entry is not an efficacy result. |
Related Trials
| Registry ID | Status / phase | Relationship | What it supports | What it does not prove |
|---|---|---|---|---|
| NCT05938920 | Published China phase 2a study | The published randomized phase 2a China trial (NCT05938920) enrolled 71 participants for 12 weeks. Treatment-emergent adverse events were the primary endpoint; forced vital capacity was secondary. The highest-dose arm showed a favorable FVC signal. The original abstract also reports liver toxicity and diarrhea among the most common reasons for treatment discontinuation. | The specific trial identity, design or dated status cited in this profile. | No survival benefit, reversal of human aging or superior clinical success of the overall AI platform follows from this short phase 2a result or from phase 3 entry. |
| NCT05975983 | Separate US phase 2a; old recruiting label, current enrollment unconfirmed | The issuer prospectus states that the US phase 2a trial was put on hold in May 2025 and the hold lifted in October 2025 following updates to safety monitoring and study documents. This review has not inspected an FDA hold or lift letter. The separate US record is NCT05975983, protocol INS018-055-004. It still lists recruiting, but its last posted update is 12 November 2025 and estimated completion is past; current US enrollment cannot be confirmed from that stale record. | The specific trial identity, design or dated status cited in this profile. | No survival benefit, reversal of human aging or superior clinical success of the overall AI platform follows from this short phase 2a result or from phase 3 entry. |
| NCT07687459 | Phase 3 recruiting label posted 13 October 2026; planned enrollment 320 | GENESIS-IPF-3 (NCT07687459) is registered phase 3, recruiting in the update posted 13 October 2026, with estimated enrollment 320 and a 52-week FVC-decline primary endpoint. The issuer reported first enrollment/dosing in September 2026. | The specific trial identity, design or dated status cited in this profile. | No survival benefit, reversal of human aging or superior clinical success of the overall AI platform follows from this short phase 2a result or from phase 3 entry. |
Timeline / Milestones
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China phase 2a paper published
Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF) / Xu et al. A generative AI-discovered TNIK inhibitor for idiopathic pulmonary fibrosis: a randomized phase 2a trial
The published randomized phase 2a China trial (NCT05938920) enrolled 71 participants for 12 weeks. Treatment-emergent adverse events were the primary endpoint; forced vital capacity was secondary. The highest-dose arm showed a favorable FVC signal. The original abstract also reports liver toxicity and diarrhea among the most common reasons for treatment discontinuation.
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Prospectus reported US hold/lift history
InSilico Medicine Cayman TopCo global offering prospectus
The issuer prospectus states that the US phase 2a trial was put on hold in May 2025 and the hold lifted in October 2025 following updates to safety monitoring and study documents. This review has not inspected an FDA hold or lift letter.
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Phase 3 registry update posted
InSilico Medicine Cayman TopCo: first patient enrolled and dosed in GENESIS-IPF-3 / NCT07687459 original trial record
GENESIS-IPF-3 (NCT07687459) is registered phase 3, recruiting in the update posted 13 October 2026, with estimated enrollment 320 and a 52-week FVC-decline primary endpoint. The issuer reported first enrollment/dosing in September 2026.
Source Posture
Trial registries
Sponsor-submitted design/status metadata; posted or completed status does not establish efficacy.
Company filings / disclosures
The issuer describes its own legal or development history; filing does not independently validate clinical benefit.
Original scientific reports
Original results abstract checked. Peer review does not establish independent replication.
Editorial interpretation
No survival benefit, reversal of human aging or superior clinical success of the overall AI platform follows from this short phase 2a result or from phase 3 entry.
Evidence / Claim Boundary
What has been published
A randomized phase 2a study in China enrolled 71 participants for 12 weeks. Its primary endpoint concerned treatment-emergent adverse events; lung function measured by forced vital capacity was secondary. The highest-dose arm showed a favorable lung-function signal, while liver toxicity and diarrhea were reported among the common reasons for treatment discontinuation. That combination warrants follow-up rather than an unqualified safety or efficacy conclusion.
The US history needs attribution
The December 2025 issuer prospectus says the US phase 2a study was placed on hold in May 2025 and allowed to resume in October after safety-monitoring and study-document updates. This is the issuer’s account; an FDA hold or lift letter was not reviewed. The US record, NCT05975983, is separate from the published China trial. Its recruiting label comes from a November 2025 update and does not confirm current enrollment.
Development has moved on
The later GENESIS-IPF-3 study, NCT07687459, is registered as recruiting in the update posted 13 October 2026. It plans approximately 320 participants and evaluates the rate of lung-function decline over 52 weeks. The issuer reported first enrollment and dosing in September. Entry into phase 3 is a development milestone, not a phase 3 result.
What This Does Not Prove
Evidence limits
No survival benefit, reversal of human aging or superior clinical success of the overall AI platform follows from this short phase 2a result or from phase 3 entry.
Detailed Sources
View detailed source table
Trial registries
| Source | Type | Supports | Limitation | Link |
|---|---|---|---|---|
| Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Sponsor-submitted trial registry | Exact trial design and dated registry status. 2025-12-11 | Sponsor-submitted design/status metadata; posted or completed status does not establish efficacy. | Original source |
| NCT05975983 original trial record | Sponsor-submitted trial registry | Exact trial design and dated registry status. 2025-11-12 | Sponsor-submitted design/status metadata; posted or completed status does not establish efficacy. | Original source |
| NCT07687459 original trial record | Sponsor-submitted trial registry | Exact trial design and dated registry status. 2026-10-13 | Sponsor-submitted design/status metadata; posted or completed status does not establish efficacy. | Original source |
Company filings / disclosures
| Source | Type | Supports | Limitation | Link |
|---|---|---|---|---|
| InSilico Medicine Cayman TopCo global offering prospectus | Issuer prospectus | Issuer-reported US May hold and October lift; no FDA letter verification. | The issuer describes its own legal or development history; filing does not independently validate clinical benefit. | Original source |
| InSilico Medicine Cayman TopCo: first patient enrolled and dosed in GENESIS-IPF-3 | Issuer filing / disclosure | Issuer identity and announced phase 3 enrollment/dosing milestone. | Issuer-reported milestone; trial entry is not a result. | Original source |
Original scientific reports
| Source | Type | Supports | Limitation | Link |
|---|---|---|---|---|
| Xu et al. A generative AI-discovered TNIK inhibitor for idiopathic pulmonary fibrosis: a randomized phase 2a trial | Original scientific article | China safety-primary study, secondary lung-function signal and adverse-outcome context. | Original results abstract checked. Peer review does not establish independent replication. | Original source |
Confidence / Methodology
Confidence
Bounded source-reviewed profile; independent specialist clearance is not implied.
Methodology note
Facts and registry labels checked as of 2026-10-19. Company disclosures, trial records, original scientific reports and regulatory documents are identified by source type below. Editorial interpretation is distinct from a demonstrated treatment result.
Last reviewed
2026-10-19