Etavopivat in Anemia, Sickle Cell: NCT06198712 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 2
Clinical phase
Recruiting
Recruitment status
95
Planned enrollment
2028-02-23
Primary-completion proxy
Executive view
NCT06198712 evaluates Etavopivat in Anemia, Sickle Cell. The disclosed sponsor is Forma Therapeutics, Inc., the design is Interventional, and the geographic footprint is Lebanon, Canada, Turkey, United Kingdom, Nigeria, Kenya, France. The first listed primary endpoint is Single-dose: maximum plasma concentration (Cmax), assessed over During the 24-week primary treatment period.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT06198712 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Anemia, Sickle Cell landscape. Drug & Asset MCP drug_fetch was queried for Etavopivat, while Company & Deal Intelligence MCP organization_fetch was queried for Forma Therapeutics, Inc..
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT06198712 | Etavopivat | Phase 2 / Recruiting | Forma Therapeutics, Inc. | Lebanon, Canada, Turkey, United Kingdom, Nigeria, Kenya, France | Single-dose: maximum plasma concentration (Cmax) During the 24-week primary treatment period | 2028-02-23 |
| NCT06481306 | BMS-986470 | Phase 1/2 / Recruiting | Bristol Myers Squibb Co. | Canada, United States, United Kingdom, Italy, France | Number of participants with adverse events (AEs) Up to 26 months | 2027-01-06 |
| PACTR202406801520269 | Etavopivat | Phase 3 / Pending | Sponsor not reported | Ghana, Kenya, Nigeria, Uganda | Timing not reported | |
| NCT06464458 | Hydroxycarbamide | Not Applicable / Unknown status | Les Hopitaux Universitaires de Strasbourg | France | Comparison of the time to obtained MTD in 2 groups of sickle cell patients on hydroxyurea with different treatment foll… Theoretical start date: January 2023 Duration of inclusion period: 30… | 2025-08-07 |
| CTRI/2024/06/068363 | Desidustat | Phase 2 / Completed | Zydus Lifesciences Ltd. | India | 2025-08-02 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT06198712 is a Phase 2, recruiting study with 95 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “Single-dose: maximum plasma concentration (Cmax)” over “During the 24-week primary treatment period.” No additional primary-endpoint description was returned in the selected field set.
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 95 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Anemia, Sickle Cell. These records do not establish direct evidence for NCT06198712 unless the registration number matches.
A Phase 1/2/3 Study to Evaluate the Safety and Efficacy of a Single Dose of Autologous CRISPR-Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (CTX001) in Subject…
Phase 2/3; n=63; Percentage of Participants Who Have Not Experienced Any Severe Vaso-occlusive Crisis (VOC) for at Least 12 Consecutive Months (VF12) After Exa-cel Infusion = 91.3 Percentage of participants (95% Confidence Interval, 79.2 - 97.6) Source: https://clinicaltrials.gov/ct2/show/results/NCT03745287
Evaluation of The Use of Hydroxyurea in Treating Children With Sickle Cell Anemia in Central Africa's Rural Area
Not Applicable; n=69; HbF(12 months) = 3.0 fold Source: https://pubmed.ncbi.nlm.nih.gov/42577886/
Reduced Intensity Conditioning (RIC) Regimen for Patients With Non-malignant Disorders
Phase 2; n=56; Number of Participants With Engraftment = 53 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT01050855
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Etavopivat is indexed as Small molecule drug with PKLR biology and a global stage of Phase 3. The asset profile lists Forma Therapeutics Holdings, Inc. as an originator or developer.
Forma Therapeutics, Inc. is indexed in United States with the website http://www.formatherapeutics.com. FORMA Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of transformative medicines. The record lists 7 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Etavopivat is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT06198712
Protocol source: https://clinicaltrials.gov/study/NCT06198712
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 28 September 2026.
Etavopivat in Anemia, Sickle Cell is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Single-dose: maximum plasma concentration (Cmax) and 2028-02-23 the leading decision points.
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