A Phase IIb, Randomised, Multicentre, Double-Blind Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure.

International, Multicenter and Double-Blind study. The purpose is to measure the effect of baxdrostat in combination with dapagliflozin compared with baxdrostat/placebo on albuminuria, as well as safety, in participants with chronic kidney disease and high blood pressure.

Start Date05 Dec 2025

Sponsor / Collaborator

AstraZeneca PLC

NCT07007793

/ RecruitingPhase 3

A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism

This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of baxdrostat versus placebo, on the reduction of Seated Blood Pressure (SBP) and achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) in approximately 180 participants ≥ 18 years of age with Primary Aldosteronism (PA), with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics.
Baxdrostat (or placebo) will be administered once daily, up-titrated after 2 weeks based on clinical response and tolerability.
The study is planned to be conducted globally in approximately 90 study centres and 12 countries.

Start Date07 Aug 2025

Sponsor / Collaborator

AstraZeneca PLC

CTRI/2025/04/085048

/ Not yet recruitingPhase 3

A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination with Dapagliflozin Compared with DapagliflozinAlone on the Risk of Incident Heart Failure and Cardiovascular Death in Participants with Increased Risk of Developing Heart Failure BaxDuo Prevent HF - BaxDuo Prevent HF

Start Date28 Apr 2025

Sponsor / Collaborator

AstraZeneca AB

[+1]

100 Clinical Results associated with Baxdrostat

100 Translational Medicine associated with Baxdrostat

100 Patents (Medical) associated with Baxdrostat

Literatures (Medical) associated with Baxdrostat

01 Mar 2026·JOURNAL OF HYPERTENSION

Prolonged aldosterone suppression and renin upregulation after baxdrostat

Article

Author: Rutten, Joost H.W. ; Danser, A.H. Jan ; Deinum, Jaap

01 Feb 2026·JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY

Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension

Article

Author: Vedin, Ola ; Chertow, Glenn M. ; Monyak, John ; Dwyer, Jamie P. ; Heerspink, Hiddo J.L. ; Maklad, Noha ; Little, Dustin J. ; Myte, Robin

Key Points:

This phase 2 trial assessed baxdrostat, an aldosterone synthase inhibitor, in participants with CKD and uncontrolled hypertension. Baxdrostat showed placebo-corrected reduction in systolic BP of –8.1 (95% confidence interval, –13.4 to –2.8) mm Hg, P = 0.003. Baxdrostat was well tolerated; hyperkalemia was the most frequent treatment-emergent adverse event.

Background:

Aldosterone increases BP and contributes to CKD progression. We evaluated the efficacy and safety of baxdrostat, an aldosterone synthase inhibitor, in participants with CKD and uncontrolled hypertension.

Methods:

This was a phase 2, randomized, double-blind, placebo-controlled, multicenter trial (NCT05432167). Eligible participants were treated with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker and had a mean seated office systolic BP ≥140 mm Hg (without diabetes) or ≥130 mm Hg (with type 2 diabetes) and a urine albumin-creatinine ratio of≥100 mg/g. Participants were randomized (1:1:1) to baxdrostat low-dose (0.5 mg up-titrated to 1 mg), high-dose (2 mg up-titrated to 4 mg), or placebo for 26 weeks. The primary end point was change from baseline in mean seated office systolic BP at week 26 in the baxdrostat pooled treatment group versus placebo. The secondary end point assessed this change by high-dose or low-dose baxdrostat; end points were tested sequentially in a hierarchal manner.

Results:

Between April 29, 2022, and May 2, 2024, 195 participants were randomized. The mean (SD) age was 66 (11) years, 32% were women, 113 (58%) were White, and 80% had type 2 diabetes. The mean (SD) baseline systolic BP was 151.2 (13.1) mm Hg; the mean (SD) baseline eGFR was 44 (14) ml/min per 1.73 m 2 , and the median (Q1, Q3) urine albumin-creatinine ratio was 714 (307, 1429) mg/g. The mean placebo-corrected change in systolic BP from baseline to week 26 for the baxdrostat pooled group was –8.1 (95% confidence interval, −13.4 to −2.8; P = 0.003) mm Hg; low-dose −9.0 (−15.1 to −2.9; P = 0.004) mm Hg; high-dose −7.2 (−13.2 to −1.2; P = 0.02) mm Hg. Hyperkalemia was recorded as an adverse event in 41% (53/128) of participants in the baxdrostat pooled group and 5% (3/64) in the placebo group.

Conclusions:

Baxdrostat reduced systolic BP in participants with CKD and uncontrolled hypertension. Hyperkalemia was reported more commonly as an adverse event with baxdrostat versus placebo.

Clinical Trial registry name and registration number::

NCT05432167.

01 Feb 2026·JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY

Baxdrostat and Other Aldosterone Synthase Inhibitors for Uncontrolled Hypertension in CKD

Article

Author: Sarafidis, Pantelis ; Theodorakopoulou, Marieta P

142

News (Medical) associated with Baxdrostat

10 Feb 2026

·www.fiercepharma.com

AstraZeneca sets sights on 25+ blockbusters by 2030 to fuel $80B revenue ambition

With more than 100 ongoing phase 3 trials and over 20 late-stage readouts slated for 2026, AstraZeneca is entering an “unprecedented catalyst-rich period,” CEO Pascal Soriot said. After ending 2025 with a strong fourth quarter, AstraZeneca management has doubled down on its ambitious “$80 billion by 2030” revenue target, outlining a roadmap to have more than 25 blockbuster medicines by the end of the decade.During AZ’s Q4 earnings call, CEO Pascal Soriot highlighted an “unprecedented catalyst-rich period.” With more than 100 ongoing phase 3 trials and over 20 late-stage readouts slated for 2026, AZ’s exec team used a big chunk of their time on the call taking inventory of key clinical programs.That large portfolio shows the value of diversification, again highlighting what Soriot called “low concentration risk.”“It’s great to have one or two big products. [It] makes you very profitable and makes you look good,” Soriot said. “But if you lose one of those, as we’ve seen happen to some actors in the industry lately, it really becomes very painful, very quickly. So this diversification, both product-wise, but also geographically, is suddenly becoming more apparent as we drive growth through therapy areas but also through regions.”AZ capped 2025 with fourth-quarter revenues of $15.5 billion, which arrived slightly above analysts’ expectations, thanks mainly to the company's oncology portfolio.But rather than commercial performance, analysts on Tuesday’s call were heavily focused on AZ’s clinical programs, wondering whether the British pharma can repeat the level of phase 3 successes it enjoyed last year.Among key 2026 readouts at the top of AZ’s—and investors’—minds are: Avanzar evaluating Daiichi Sankyo-partnered Datroway in first-line non-small cell lung cancer; Serena-4 for the oral SERD camizestrant in first-line HR-positive breast cancer; CardioTTRansform testing Ionis-partnered Wainua in transthyretin amyloid cardiomyopathy; three phase 3 trials of efzimfotase alpha in the rare metabolic bone disease hypophosphatasia; and three phase 3 studies of the IL-33 agent tozorakimab in chronic obstructive pulmonary disease (COPD). Avanzar represents the epitome of AZ’s recent efforts to help improve the probability of success of its clinical studies. With the help of artificial intelligence, the company developed a new TROP2-based biomarker in the hopes of enriching for responders to Datroway. In April 2025, AZ signed a three-way deal with Tempus AI and Pathos AI to construct a patient data-based multimodal oncology model.“My reflection of the last decade in oncology, about the success rates we’ve had, has been predicated on being able to identify the right patient populations to treat,” AZ’s oncology R&D head, Susan Galbraith, Ph.D., said on Tuesday’s call.AZ has been using real-world evidence to help design its phase 3 trials and predict control-arm performance. The hope is that AI models can help in the same way when historical literature data are lacking in certain new biomarker areas or where the biology is more complicated, Galbraith said.As for camizestrant, industry watchers are eager to see results from AZ’s first-line Serena-4 trial and the phase 3 Cambria-1 and -2 studies in early breast cancer, after Roche reported positive data for its rival oral SERD, giredestrant, in two similar settings. The key focus is if oral SERDs can break into an earlier and larger population beyond patients whose tumors have ESR1 mutations.For the first-line trial, AZ has designed the study to enrich for endocrine-sensitive patients, who are expected to respond better to oral SERDs, Galbraith said. Those patients typically experienced recurrence from early-stage disease after at least two years of standard adjuvant therapy because those that are less endocrine-sensitive typically progress more rapidly, she explained.In the adjuvant setting, the two studies target different patient populations that could potentially give AZ access to the largest group of patients, Galbraith said. While Cambria-1 allows patients to have used a CDK4/6 inhibitor, Cambria-2 allows concurrent use of a CDK4/6 inhibitor, which Galbraith said is important now that these meds are becoming the new standard in the adjuvant setting.Outside of oncology, as one analyst noted on Tuesday’s call, AZ has billed efzimfotase alpha as having the opportunity to reach $3 billion to $5 billion in peak sales. The drug’s once-every-other-week dosing is considered an upgrade from the up to once-every-two-days frequency of AZ’s Strensiq.With three phase 3 trials, AZ’s goal is again for the newer enzyme therapy to reach a broad population, Marc Dunoyer, CEO of AZ’s rare disease unit, Alexion, said on the call. Two trials are in the pediatric population—one in which patients switch from Strensiq and the other in Strensiq-naïve patients—and the third trial combines adolescents and adults.In the biopharmaceutical department, AZ is targeting the very competitive ATTR-CM field. As the largest trial in this disease, CardioTTRansform is powered to run a key subgroup analysis among patients who are on baseline treatment with Pfizer’s Vyndamax. Information here is important because it may change treatment guidelines, Sharon Barr, Ph.D., AZ’s head of biopharmaceuticals R&D, said on the call. A big question for AZ’s biopharmaceutical business is whether the company can sustain the blow from the loss of exclusivity of its SGLT-2 inhibitor Farxiga, which generated $8.4 billion in sales in 2025. The drug was also one of the first drugs selected for price negotiations under the Inflation Reduction Act, with a discount for Medicare taking effect at the beginning of this year.AZ’s biopharmaceutical business will “have a blip” following the Farxiga patent cliff, but the company has enough other growth drivers, Ruud Dobber, who leads the unit, said on the call.He pointed to the potential 2026 launch of baxdrostat for hard-to-control hypertension, noting that AZ has set the drug’s overall peak sales potential above $5 billion. Respiratory and immunology drugs Breztri and Tezspire are also expected to continue their double-digit growth, he said.

Phase 3Phase 2

10 Feb 2026

·endpoints.news

Is AstraZeneca on track to meet its $80B revenue target?

LONDON — In 2024, AstraZeneca’s CEO Pascal Soriot set a new goal : for the company to pull in $80 billion in annual sales by 2030. At that time, this target looked ambitious. But less than two years later, the drugmaker is very bullish. Soriot asserted during a media briefing in London on Tuesday that “we have a lot of reason to believe we’re very much on track to deliver our 2030 ambition, but also to grow past 2030.” If AstraZeneca can maintain its current form, he’s right. AstraZeneca’s 2025 revenues totaled $58.7 billion, up 9% from the year prior, and guided to “mid-to-high single-digit percentage” growth in the coming year. Assuming the company grows at a steady annual rate of 7%, which fits the mid-to-high-single-digit bill, its revenues in 2030 will be $85.5 billion. In fairness, Soriot has done something similar before. More than a decade ago, in 2014, he fended off a takeover bid by Pfizer, insisting that AstraZeneca, whose sales that year were just $26.1 billion, could reach $45 billion in revenue by 2023. It is fair to say this was met with general scorn from analysts and other industry watchers. Soriot tweaked this goal in 2016, citing exchange-rate fluctuations and giving the company a more modest target of 2023 revenues in excess of $40 billion. Nonetheless, the earlier goal was reached: AstraZeneca’s 2023 sales were $45.8 billion. (Not all of this was organic, of course — it got a major sales bump thanks to the rare disease drugs it obtained via its $39 billion acquisition of Alexion in 2020, for example.) So, can AstraZeneca do it again? AstraZeneca said Tuesday that it did not expect its increasingly large and advancing obesity franchise to start bringing in cash until after the 2030 deadline. And it is facing a handful of short-term headwinds, “including the loss of exclusivity for Brilinta, the impact of Soliris biosimilars and Farxiga generics,” as CFO Aradhana Sarin put it in the Tuesday briefing. The company also expects to take a hit from the so-called “most favored nation” deal it struck with the US government in October. To offset these drags on revenue, several of AstraZeneca’s as-yet-unapproved products will need to blossom into blockbusters, with Soriot saying that it currently has 16 blockbusters but hopes to have 25 by 2030. Chief among these is baxdrostat, a therapy for treatment-resistant hypertension that has posted impressive late-stage data . An approval decision is expected in the second quarter of this year, but data on a potential rival drug from Mineralys Therapeutics looked slightly better , and it will be interesting to see how this dynamic plays out in the market — particularly as Mineralys is sometimes talked of as a takeover target. Another drug AstraZeneca needs to perform is its breast cancer pill camizestrant. This is a selective estrogen receptor degrader, or SERD, which has been detailed as a success in a first-line setting, and could reach market in the first half. But Roche also has a SERD, giredestrant, which it said last month could become its biggest-ever money-spinner. The two drugs are aiming to treat slightly different populations, but once approved, oncologists could use them off-label in the same settings. And of the two drugs, Roche’s is the buzzier. But these are just two potential billion-dollar sellers — AstraZeneca wants to find nine in the next five years. It’s a big ask. But it is, perhaps, not impossible.

AcquisitionPhase 3

14 Jan 2026

·www.fiercepharma.com

JPM26: AstraZeneca's $80B revenue target 'very much within reach,' CFO says

The number of new molecules or in-market drugs with late-stage label expansion programs has grown to 37 at AstraZeneca in 2025, compared with 27 in 2021. AstraZeneca’s $80 billion revenue target for 2030 is “very much within reach,” Chief Financial Officer Aradhana Sarin said at the J.P. Morgan Healthcare Conference Tuesday.“If we have the same success rate this year as we had last year of our phase 3s, then I think the confidence increases even further,” she said.Within the drugmaker's oncology portfolio alone, AZ had 10 positive phase 3 readouts last year, which gave the company “a lot of cards that we get to play between now and 2030,” oncology business chief Dave Fredrickson said at the event.The number of new molecules or in-market drugs with late-stage label expansion opportunities at AstraZeneca grew to 37 in 2025 compared with 27 in 2021, according to a presentation by Sarin. At the same time, the non-risk-adjusted value per indication of those meds has also increased to about $1.3 billion in 2025 from about $700 million previously.As Sarin noted, analysts’ projections for AZ in 2030 have risen to match that $80 billion target, versus a consensus estimate of $67 billion when the company first floated the goal in May 2024.Within the oncology portfolio, Fredrickson suggested the PD-L1 inhibitor Imfinzi will likely be AZ’s largest oncology medicine by sales “in the midterm period” thanks to a series of new indications such as perioperative gastric cancer. But perhaps more important is the upcoming phase 3 Avanza readout for AZ and Daiichi Sankyo’s TROP2 ADC Datroway and Imfinzi in first-line metastatic non-small cell lung cancer (NSCLC).“We have very little sales of Imfinzi in stage 4 lung cancer, so this would be a really nice opportunity to grow into that setting,” Fredrickson said.If that effort is successful, Imfinzi would supplant Tagrisso, which has been AZ’s largest oncology product for a long time. In the first nine months of 2025, Tagrisso’s sales grew 10% year over year to nearly $5.4 billion, while Imfinzi’s haul jumped 25%, reaching $4.3 billion.“That doesn’t mean Tagrisso is not going to be doing well,” Fredrickson added. “It’s just because I think Imfinzi has got more engines to grow off of.” As the longtime EGFR inhibitor king, Tagrisso is facing a threat from Johnson & Johnson’s combination of Rybrevant and Lazcluze, which beat the AZ med in a head-to-head phase 3 in first-line EGFR-mutant NSCLC.“We’re continuously looking for opportunities to raise the bar and beat Tagrisso right now,” Fredrickson said. “The near- and mid-term opportunities to do that are through Tagrisso combinations.”The phase 3 Flaura2 trial recently showed that Tagrisso’s combination with chemo could help first-line patients live longer than Tagrisso alone. The readout spurred an interest among doctors to favor the combo, instead of Tagrisso monotherapy, for most patients, according to Fredrickson.Beyond chemotherapy, AZ is weighing whether to add Datroway to Tagrisso in the front-line setting.“Ideally, we’d like to be able to bring in other ADC combos with Tagrisso into the space as well,” Fredrickson said.Outside of oncology, analysts have high hopes for AZ’s Ionis-partnered transthyretin amyloidosis (ATTR) drug Wainua, which is expected to read out phase 3 ATTR-cardiomyopathy data in the second half of 2026. The Cardio-TTRansform trial is the largest ever done in ATTR-CM, and, perhaps more importantly, it could have data on whether Wainua works on top of Pfizer’s blockbuster Vyndamax (tafamidis).AZ boasts a strong presence in cardiovascular disease, including with Farxiga, and its experimental hypertension drug baxdrostat is under FDA priority review with a decision expected in the second quarter. AZ was among the first large pharma companies to have signed a most-favored-nation drug pricing deal with the Trump administration.“I think one of the things that we were encouraged by with the administration [is] that the administration understood the nuanced aspects of ensuring that life sciences continue to be competitive and robust within the United States,” Sarin said, “and that meant a phased approach to the work that we're doing.”That phased approach lies in the fact that beginning in 2026, MFN is going to first touch Medicaid, which according to Sarin represents only a low-single-digit percentage of global sales for AZ over time.“It will grow to represent multiple channels of business and multiple medicines, but it gives us the opportunity to plan to get towards that and to offset by increasing funding for innovation across the globe as the U.S. prices come down,” Sarin said.

Phase 3Priority Review

100 Deals associated with Baxdrostat

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Resistant hypertension	NDA/BLA	United States	AstraZeneca PLC	02 Dec 2025
Hyperaldosteronism	Phase 3	United States	AstraZeneca PLC	07 Aug 2025
Hyperaldosteronism	Phase 3	China	AstraZeneca PLC	07 Aug 2025
Hyperaldosteronism	Phase 3	Japan	AstraZeneca PLC	07 Aug 2025
Hyperaldosteronism	Phase 3	Australia	AstraZeneca PLC	07 Aug 2025
Hyperaldosteronism	Phase 3	Canada	AstraZeneca PLC	07 Aug 2025
Hyperaldosteronism	Phase 3	France	AstraZeneca PLC	07 Aug 2025
Hyperaldosteronism	Phase 3	Germany	AstraZeneca PLC	07 Aug 2025
Hyperaldosteronism	Phase 3	India	AstraZeneca PLC	07 Aug 2025
Hyperaldosteronism	Phase 3	Italy	AstraZeneca PLC	07 Aug 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06336356 (CTgov)	Phase 2	Hypertension	48	Baxdrostat (Baxdrostat 2 mg)	rpfwdyvdlt = eolwuefoqr vuaneglkeh (vusawhlilz, bvnznjjagh - uvjybgzhro) View more	-	17 Dec 2025
				placebo (Placebo)	rpfwdyvdlt = uhgydzkinm vuaneglkeh (vusawhlilz, xeytyzxjhz - ummkuffixd) View more
NCT05432167 (FigHTN, ASN2025)	Phase 2	Hypertensive Nephropathy	-	Baxdrostat	yqsgquvxmv(bkhbkuozzs) = lktsmnmbtp bkfvdjtjcp (lgbjexpckt ) View more	Positive	08 Nov 2025
				placebo	yqsgquvxmv(bkhbkuozzs) = nwewdegunn bkfvdjtjcp (lgbjexpckt ) View more
NCT06034743 (BaxHTN, Pubmed \| N Engl J Med)	Phase 3	Resistant hypertension	794	Baxdrostat 1 mg	iddxqxkffz(nrilgyibdn) = jmgcagmgoj plnaahwmtr (xnqkzkfymf, -16.5 to -12.5) View more	Positive	09 Oct 2025
				Baxdrostat 2 mg	iddxqxkffz(nrilgyibdn) = dvphrdehio plnaahwmtr (xnqkzkfymf, -17.6 to -13.7)
NCT06168409 (Bax24, Company_Website) Manual	Phase 3	Resistant hypertension	-	Baxdrostat (2mg) + standard of care	matwkafwga(mucsfznocl) = Baxdrostat demonstrated a statistically significant and highly clinically meaningful reduction in ambulatory 24-hour average SBP compared with placebo at 12 weeks. Efficacy was observed throughout the 24-hour period, including early morning, when patients with hypertension are at a higher risk of cardiovascular events. jgruxnjrai (banedaumpp ) Met	Positive	07 Oct 2025
				Placebo + standard of care
NCT06034743 (BaxHTN, N Engl J Med \| Company_Website) Manual	Phase 3	Hypertension	796	Baxdrostat 1 mg	cquqkctzpd(aqollfurmf) = vwdzldgzye akvwdfdwwq (njolmdartr, -16.5 to -12.5)	Positive	30 Aug 2025
				Baxdrostat 2 mg	cquqkctzpd(aqollfurmf) = njweksrsad akvwdfdwwq (njolmdartr, -17.6 to -13.7)
NCT06034743 (BaxHTN, Company_Website) Manual	Phase 3	Hypertension	796	Baxdrostat 1 mg	psontjoyov(phjutscqpk) = baxdrostat at two doses (2mg and 1mg) demonstrated a statistically significant and clinically meaningful reduction in mean seated systolic blood pressure (SBP) compared with placebo at 12 weeks eufsotziwz (uodqnobgrz ) Met View more	Positive	14 Jul 2025
				Baxdrostat 2 mg
NCT04605549 (SPARK, N Engl J Med \| Pubmed) Manual	Phase 2	Hyperaldosteronism	15	Baxdrostat	cncctnfhpm(bwqfcjcwkg) = mmfmzxljqd nvrwgtxokp (petbbwhgif, 9.0) View more	Positive	13 Jul 2025
NCT06034743 (BaxHTN, ESH2025)	Phase 3	Resistant hypertension	782	Baxdrostat 2 mg	mgbxdwxbec(qaxptvpvpj) = paznannfmr twiykglukp (cknrnumejk, 11.8) View more	Positive	23 May 2025
NCT05432167 (FigHTN, CTgov)	Phase 2	Hypertension \| Chronic Kidney Diseases	195	Placebo	qhcntdefmn(qmlhnhnhjb) = dlwuqevmbc ucnxgwyitd (tnvteqojdo, 2.231) View more	-	20 May 2025
NCT05459688 (CTgov)	Phase 2	Hypertension	175	CIN-107	ipgunkgwdr = ucsascdcbe gjgzkbanab (oypzadzuoc, xlmlyvdtzq - ryyyjtgeid) View more	-	16 Dec 2024

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