Taldefgrobep alfa_Dosage, benefits & legal status
Also known as talditercept alfa, BHV-2000, BMS-986089, RO7239361, RO-7239361
Failed in the muscle disease where a rival succeeded, then moved to the GLP-1 muscle-loss problem.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Taldefgrobep alfa?
Plain language first. The technical label stays, but it never stands alone.Overview
Myostatin is the body's brake on muscle growth, and blocking it is an old idea with a long record of disappointment. This drug is the latest attempt. It has already been through two diseases. Bristol Myers Squibb built it and tested it in Duchenne muscular dystrophy, and Roche stopped that trial early once it was clear the drug would not hit its target. Biohaven then ran a phase 3 in spinal muscular atrophy, and that one missed too, and it stung more because a competitor's myostatin drug succeeded in the same disease and is now approved. What makes it interesting to anyone taking a GLP-1 is the reason it got a third life. In the failed trial, the people on the drug lost significantly more body fat than the control group. Biohaven took that leftover finding and started an obesity trial, betting the drug can strip fat while sparing the muscle that GLP-1 drugs tend to take with them. That trial has reported nothing yet. It was due to report in late 2026 and has slipped a full year to late 2027, because the company is adding a group that takes it alongside a GLP-1.
Taldefgrobep alfa is a recombinant fusion protein, not a short peptide: an adnectin built on the tenth fibronectin type III domain, joined to a human IgG1 Fc fragment through a 17-residue synthetic linker, and supplied as a homodimer of two 340-residue chains. It binds growth differentiation factor 8, carried on this site as GDF-8 or myostatin, lowering free myostatin, and the resulting complex also acts as an activin 2b receptor antagonist, so Biohaven calls it a myostatin-activin pathway inhibitor rather than a myostatin antibody. Its phase 3 trial in spinal muscular atrophy missed its primary endpoint. It is now in a phase 2 trial in overweight and obesity, where no efficacy data has been reported, and its registry entry under the FDA's preferred name is talditercept alfa.
What it's used for
Tested in spinal muscular atrophy, where the phase 3 missed its primary endpoint, and earlier in Duchenne muscular dystrophy, where the trial was stopped early. Now in a phase 2 trial in adults with overweight and obesity. Approved in no country for anything.
How does Taldefgrobep alfa work?
What it does in the body, and where.Four drugs on this site aim at this pathway and they are built very differently. This one is the only adnectin among them, and it is the one with the most complicated history.
- 01What it is made of, and it is not a peptideThe FDA's registry describes it as an adnectin derived from the tenth fibronectin type III domain, synthetic clone PRD-1474, fused to a human IgG1 Fc fragment through a 17-residue synthetic linker, as a homodimer of two 340-residue chains. An adnectin is a small engineered scaffold protein that does an antibody's binding job without being an antibody. Set beside the rest of this family, apitegromab and trevogrumab are true antibodies, bimagrumab is an antibody against the receptor instead of the hormone, ACE-031 and ACE-083 are receptor and follistatin traps, and this is a fourth architecture again.
- 02It does two things, and the second one is why the name changedIt binds myostatin, lowering the amount of free myostatin available to signal. Then the drug-myostatin complex itself acts as an antagonist at the activin 2b receptor, so the pathway is blocked at a second point. That is why Biohaven calls it a myostatin-activin pathway inhibitor rather than a myostatin inhibitor, and why its effect is not interchangeable with a plain anti-myostatin antibody. Trade coverage has also described it as blocking activin A.
- 03Releasing the brake is the easy part; the record says the hard part is functionMyostatin limits muscle growth, and blocking it reliably adds lean mass. The question this class keeps failing is whether that added mass does anything. In spinal muscular atrophy this drug was measured against a motor function scale over 48 weeks and did not separate from placebo. That is the clearest available test of whether its lean mass translates.
- 04The obesity rationale, and where it actually came fromThe case for obesity is that GLP-1 drugs take muscle along with fat, so a drug that spares muscle could improve the quality of the weight lost rather than the quantity. Two pieces of evidence sit behind it and neither is a human obesity result. In mice, the drug cut fat and raised lean mass without changing food intake, and Biohaven points out that this is the opposite of how incretins work, and a second mouse study paired it with a GLP-1 and reported more weight and fat loss and more lean mass than the GLP-1 alone. In people, the signal is a secondary finding from the failed spinal muscular atrophy trial, where total body fat mass fell significantly more on drug than on control.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
The obesity program, where the interest is and the data is not
Investigational- human-earlyPhase 2b NCT07281495 in overweight and obesity: 150 estimated participants at 20 US sites, under the skin once weekly or once every four weeks against placebo, actual start November 24, 2025, primary outcome percent change in total body weight at week 24.
- RegulatoryNo efficacy result has been reported. Biohaven stated on October 29, 2026 that the study is being amended to add an assessment in combination with a GLP-1-based therapy, and that topline data for both the monotherapy and combination portions is now expected in the second half of 2027.
- No dataThat is a full year of slippage. The same company guided to topline in the second half of 2026 in its first-quarter 2026 update and again on a mid-2026 conference poster.
- No dataThe trial registry has not caught up. Its record was last updated on March 20, 2026, lists monotherapy schedules only, and describes no GLP-1 combination, so the amendment exists in the company's filings and not yet in the public trial record.
Two failed indications, and a rival that succeeded in one of them
tested-and-failed- Human trialRESILIENT, phase 3 in spinal muscular atrophy, NCT05337553: 206 ambulatory and non-ambulatory patients, add-on to SMN upregulators, missed its primary endpoint on MFM-32 at 48 weeks.
- No dataApitegromab, a myostatin antibody carried on this site, succeeded in spinal muscular atrophy and is approved for it. Two drugs aimed at the same hormone in the same disease went opposite ways. That is the strongest available argument that the details of how you block this pathway matter.
- Human trialSPITFIRE, phase 2/3 in Duchenne muscular dystrophy, NCT03039686: 166 ambulatory boys, primary endpoint the North Star Ambulatory Assessment. Roche discontinued it after preliminary data indicated the primary endpoint would not be met. Sourcing tier: read through a trade reproduction, not from the trial record itself.
- No dataBiohaven attributed the spinal muscular atrophy result partly to genetic polymorphisms enriched in non-Caucasian participants and called it a potentially facile biomarker. This is a post-hoc company explanation, not a tested finding.
The animal work the obesity case rests on
Early research- Animal studyDiet-induced obese mice, announced October 2023: untreated mice gained 31% fat mass, while treated mice gained 25% lean mass and lost 11% of baseline fat. Insulin and leptin were lower on drug.
- Animal studyFood intake did not differ over time between treated and untreated mice, and Biohaven contrasts with incretin drugs, where reduced intake is consistent. A mechanism claim resting on mouse feeding behavior.
- Animal studyA second mouse study announced May 2024 paired the drug with a GLP-1 agonist and reported greater reductions in body weight and fat mass and a larger increase in lean muscle than GLP-1 alone. This is the direct basis for the combination group being added to the human trial.
Identity, and a name change nobody has adopted
none- lab-analysisFDA registry UNII 766C38JSAR, substance class protein, two subunits of 340 residues each, INN 10661. Development codes BMS-986089 from Bristol Myers Squibb, who built it, and RO7239361 from Roche, who licensed it in 2017, are both stored in the registry.
- lab-analysisThe registry's preferred name is talditercept alfa, flagged as official with both USAN and INN as naming organizations, and it is the only one of the record's twelve names marked preferred. Taldefgrobep alfa is also official with the same two organizations, and marked not preferred.
- No dataNobody uses the preferred name. Biohaven's own filings, the trial records and the published literature all say taldefgrobep alfa, so this page is filed under that name with the other carried as an alias.
- RegulatoryThe drug received FDA fast track designation for spinal muscular atrophy in February 2023, in addition to an earlier US orphan drug designation. Both predate the failed trial and neither speaks to whether it works.
The first error is the failed indication. Coverage often names Duchenne muscular dystrophy as the setback, and the Duchenne trial was indeed stopped early, but that was Roche in an earlier era of the molecule. The consequential failure is the phase 3 in spinal muscular atrophy, read out against a motor function scale and missed. The second is treating the obesity program as though it has results. It has none. Its readout moved from the second half of 2026 to the second half of 2027, so anything presented as this drug's weight-loss data is either mouse work or a secondary measure from the trial that failed. The third is calling it a myostatin antibody. It is an adnectin fused to an antibody fragment, and it blocks the pathway at the activin receptor as well as at the hormone, so Biohaven uses the longer name. The fourth is the drug's own name: the FDA registry's preferred official name is talditercept alfa, and almost no source uses it. The fifth is mixing it up with apitegromab, a drug that went the other way in the same disease and is approved there.
The published record
Papers about Taldefgrobep alfa
Searched: taldefgrobep alfa, talditercept alfa, BHV-2000, BMS-986089, RO7239361, RO-7239361.
Left out: apitegromab (THE critical rejection. A myostatin ANTIBODY already on this site that SUCCEEDED in spinal muscular atrophy and is FDA-approved for it, where this drug failed in the same disease. Two drugs aimed at the same hormone going opposite ways is the single most informative comparison on the page, and conflating them would invert both records); trevogrumab (another myostatin antibody on this site, in Regeneron's obesity combination work. Same pathway, different architecture, and it has its own GLP-1 muscle-preservation story that must not be merged with this one); bimagrumab (on this site and correctly typed there as an ACTIVIN RECEPTOR antibody, not a myostatin antibody. It also has a semaglutide combination result. Closest in mechanism to this drug's second mode of action, so the most likely source of borrowed data); ACE-031 (a myostatin/activin TRAP on this site, a receptor-Fc fusion. Architecturally the nearest neighbor and a different molecule); ACE-083 (a follistatin-based fusion protein on this site. The only other card whose sequenceData uses not-a-single-sequence, for the same reason); GDF-8 (THIS DRUG'S TARGET, and it has its own card here. The registry's own systematic name for taldefgrobep is an adnectin against human growth differentiation factor 8, so a target search returns both); myostatin (the pathway term, returning nine existing cards); RESILIENT (the failed phase 3's trial name, which also collides with unrelated trials of that name); SPITFIRE (the discontinued Duchenne trial's name); Scholar Rock (apitegromab's developer, the company that succeeded where this one failed); adnectin (the scaffold class, returning unrelated fibronectin-domain therapeutics).
3 papers tagged human · 2 not reviews or lab · 0 clinical trial publications
Furthest stage reached: No clinical trial on record
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count. A preprint and its journal version count once.
At a glance
Four things to know about Taldefgrobep alfa
Evidence
Investigational
Category
Muscle building
Common vial
Varies
Half-life
Not published; the Fc fragment is there to make it long-acting
How much, and do you cycle it?
The range, and whether you take breaks.No dose has been published for any indication, once weekly or once every 4 weeks in the phase 2 obesity trial. Weekly or monthly through a 24-week blinded period, then a 24-week open-label extension Trial dose
The structure is the trial's, not a regimen anyone has established. Biohaven's own filing describes about 150 participants randomized over a 24-week double-blind period followed by a further 24 weeks in which everyone receives the drug.
Not published; the Fc fragment is there to make it long-actingNo figure
No half-life figure has been published. The structure says something even so: fusing a binding domain to an antibody Fc fragment is the standard way to keep a protein in circulation for days to weeks, and the obesity trial's once-monthly arm only makes sense for a molecule with that kind of persistence. Biohaven presented pharmacokinetic modeling at a 2026 conference to pick the weekly and monthly schedules without publishing the parameters behind it.
You can compare this against the whole library to see where it sits.
How do I dose and price it?
Enter your vial and your dose. Pick a mix. We show the draw and the cost.The vial holds a fixed amount of drug. Adding more water does not make more drug, it just spreads it thinner, so you draw a bigger number on the syringe for the same dose.
Choose your mix
Measuring the water1 mL = one full 100-unit syringe.
How do you store it?
Before mixing, and after.Nothing to store: it is not sold anywhere.
Taldefgrobep alfa has never been marketed, so there is no vial, pen or bottle to keep at home. Supplies for a trial are made, stored and dispensed by the sponsor and the trial pharmacy under conditions set in the protocol. Anything offered for sale under this name did not come from that supply chain.
What are the side effects and cautions?
Known cautions and warnings for this compound.Who should avoid it
- Any expectation of access, since this is approved nowhere and is not sold by any supplier
- Reading the obesity program as having results, since the phase 2 has reported no efficacy data and its readout has moved to the second half of 2027
- Treating the fat-loss finding as a trial result in its own right, since it came from secondary measures in a trial that missed its primary endpoint in a different disease
- Confusing it with apitegromab, a myostatin antibody that succeeded in spinal muscular atrophy and is approved for it. This drug failed in that disease
Stop and get help
- Given inside clinical trials under supervision, so there is no self-directed course to stop
- No stopping rules have been published, because no safety signal requiring one has been reported
Common effects
- Nothing has been published for the obesity trial. The neuromuscular trials did not report a pattern of common effects that drove any decision, and both program changes were made on efficacy.
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Taldefgrobep alfa approved?
And where the numbers on this page come from.No. Taldefgrobep alfa is not approved anywhere and is currently in company-run clinical trials. There is no legal route to obtain it outside a trial.
- Approval statusInvestigational
- RouteUnder the skin, weekly or every 4 weeks, by autoinjector in the obesity trial
- Checked9 November 2026
- DoseNo dose has been established in people.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesBiohaven third-quarter 2026 business update, filed with the SECClinicalTrials.gov record NCT07281495FDA Global Substance Registration System, stored names for UNII 766C38JSARInternational Journal of Molecular Sciences, taldefgrobep alfa and the phase 3 RESILIENT trialBiohaven quarterly report for the period ended September 30, 2025, filed with the SECBiohaven pharmacokinetic and pharmacodynamic modeling poster, 2026
What has happened recently
Approved in no country for any indication. Current trial: NCT07281495, phase 2b in overweight and obesity, sponsor Biohaven Therapeutics, active and not recruiting, 150 estimated participants at 20 US sites, actual start November 24, 2025, with the registry's estimated primary completion of September 2026 now superseded by the company's own guidance of a second-half 2027 topline following an amendment to add a GLP-1 combination group. Past trials: RESILIENT, NCT05337553, phase 3 in spinal muscular atrophy, missed its primary endpoint; SPITFIRE, NCT03039686, phase 2/3 in Duchenne muscular dystrophy, discontinued before completion. FDA fast track designation for spinal muscular atrophy in February 2023 and a prior US orphan drug designation. Originated at Bristol Myers Squibb as BMS-986089, licensed to Roche in 2017 as RO7239361, now with Biohaven as BHV-2000. Registered under the FDA's preferred name talditercept alfa.
You can compare this against the whole library, or read how to check a seller.
What else is like Taldefgrobep alfa?
Others in Muscle building, side by side.If you're weighing Taldefgrobep alfa, it's worth reading Tesamorelin, Ipamorelin, and CJC-1295 no DAC (Mod GRF 1-29) in the same class.
Failed in the muscle disease where a rival succeeded, then moved to the GLP-1 muscle-loss problem.
- Dose
- No dose has been published for any indication
- How often
- Once weekly or once every 4 weeks in the phase 2 obesity trial
An approved shot proven to shrink stubborn belly fat.
- Dose
- 1.28 up to 2 mg per day, depending on which product you have
- How often
- Daily
A gentle shot that nudges your body to release its own growth hormone.
- Dose
- 0.2 up to 0.3 mg per dose (start low, increase slowly)
- How often
- Daily, often at night
A short-acting growth-hormone pulse, usually paired with ipamorelin.
- Dose
- 0.1 mg per dose
- How often
- Daily to 2x daily
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
- How to Read a Peptide COA
What the purity number does and does not tell you, and how to spot an edited report.
- How to Vet a Peptide Vendor
Independent COAs, HPLC purity, and the red flags that mean walk away.
Sources
- Biohaven third-quarter 2026 business update, filed with the SEC(2026)Dated October 29, 2026. States that the phase 2 obesity study remains ongoing with a planned addition of a GLP-1 combination cohort and that topline data is expected in the second half of 2027. Describes the drug as targeting the myostatin-activin pathway with the goal of increasing lean mass while reducing fat mass, given under the skin once weekly and once monthly in overweight adults and adults living with obesity. The accompanying release states that the amendment is the reason for the revised timing.
- ClinicalTrials.gov record NCT07281495(2026)Phase 2b, multicenter, randomized, double-blind, placebo-controlled, multiple-dose with an open-label extension, in adults with overweight and obesity. Lead sponsor Biohaven Therapeutics Ltd. Active and not recruiting, 150 estimated enrollment, 20 sites all in the United States. Interventions are taldefgrobep alfa, also called BHV-2000, or matching placebo under the skin either once weekly or once every four weeks, with no dose amounts listed. Actual start November 24, 2025, estimated primary completion September 2026, last update posted March 20, 2026. Primary outcome is percent change in total body weight from baseline to week 24. No GLP-1 combination is described anywhere in the record.
- FDA Global Substance Registration System, stored names for UNII 766C38JSAR(2026)Twelve names. TALDITERCEPT ALFA is official, carries both USAN and INN as naming organizations, and is the only name marked preferred. Taldefgrobep Alfa is also official with the same two organizations and is marked not preferred. The systematic names describe an adnectin from the tenth fibronectin type III domain, synthetic clone PRD-1474, against human growth differentiation factor 8, as an immunoglobulin G1 human Fc fragment fusion protein with a synthetic 17-amino-acid linker. Development codes BMS-986089, RO7239361 and RO-7239361 are all stored. The substance record gives UNII 766C38JSAR, class protein, two subunits of 340 residues, INN 10661.
- International Journal of Molecular Sciences, taldefgrobep alfa and the phase 3 RESILIENT trial(2024)Volume 25, issue 19, article 10273, published September 24, 2024, twelve authors with Laurent Servais first. A review by authors including Biohaven staff rather than a results paper: it sets out myostatin's role in muscle, the preclinical and clinical development of the drug, and the design of the phase 3 trial in spinal muscular atrophy, and describes the safety profile in neuromuscular disease as favorable. It predates the trial's failure. DOI resolved at Crossref before being recorded here.
- Biohaven quarterly report for the period ended September 30, 2025, filed with the SEC(2025)Describes the preclinical basis for the obesity program. In diet-induced obese mice announced October 2023, untreated mice gained 31% in fat mass while treated mice gained 25% in lean mass from baseline and lost 11% of baseline fat, with lower insulin and leptin and no difference in food intake over time, a point the filing contrasts with incretin mimetics. A further mouse study announced May 2024 combined the drug with a GLP-1 agonist and reported greater reductions in body weight and fat mass and a larger increase in lean muscle than GLP-1 alone. States that about 150 participants would be randomized over a 24-week double-blind period followed by a further 24 weeks of open-label treatment.
- Biohaven pharmacokinetic and pharmacodynamic modeling poster, 2026(2026)States that modeling was used to choose the weekly and every-four-week schedules for the phase 2 study, that the study was fully enrolled, and that topline results were expected in the second half of 2026. Frames the rationale as GLP-1 receptor agonists achieving large weight reductions in part through excessive loss of lean muscle mass. No milligram doses and no pharmacokinetic parameters are reproduced here, because the figures were not read at source.
Beyond these, 4 records are indexed. Browse the records